<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01665053</url>
  </required_header>
  <id_info>
    <org_study_id>S2067</org_study_id>
    <secondary_id>G120123</secondary_id>
    <nct_id>NCT01665053</nct_id>
  </id_info>
  <brief_title>The EVOLVE II Clinical Trial To Assess the SYNERGY Stent System for the Treatment of Atherosclerotic Lesion(s)</brief_title>
  <official_title>EVOLVE II: A Prospective Multicenter Trial to Assess the Safety and Effectiveness of the SYNERGY Everolimus-Eluting Platinum Chromium Coronary Stent System (SYNERGY Stent System) for the Treatment of Atherosclerotic Lesion(s)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Scientific Corporation</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the safety and effectiveness of the SYNERGY&#xD;
      Everolimus-Eluting Platinum Chromium Coronary Stent System for the treatment of subjects with&#xD;
      atherosclerotic lesion(s) ≤ 34 mm in length (by visual estimate) in native coronary arteries&#xD;
      ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A concurrent, non-randomized, single-arm, pharmacokinetic (PK) substudy and a consecutive,&#xD;
      non-randomized, single-arm, Diabetes substudy will also enroll under the EVOLVE II protocol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">December 22, 2018</completion_date>
  <primary_completion_date type="Actual">September 2014</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of Participants With Target Lesion Failure (TLF) at 12 Months</measure>
    <time_frame>12 months</time_frame>
    <description>TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Target Lesion Revascularization (TLR) at 12 Months.</measure>
    <time_frame>12 months</time_frame>
    <description>The TLR overall rate includes: TLR Percutaneous Coronary Intervention (PCI) &amp; TLR Coronary Artery Bypass Graft (CABG).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Target Vessel Revascularization (TVR) at 12 Months.</measure>
    <time_frame>12 months</time_frame>
    <description>TVR overall includes: TVR PCI &amp; TVR CABG.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Target Vessel Failure (TVF) at 12 Month.</measure>
    <time_frame>12 months</time_frame>
    <description>Target Vessel Failure is defined as any ischemic-driven revascularization of the target vessel, MI related to the target vessel, or any cardiac death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Myocardial Infarction at 12 Month.</measure>
    <time_frame>12 months</time_frame>
    <description>The MI rate includes: MI's related to the Target Vessel, MI's with unknown relationship to the Target Vessel and MI's not related to the Target Vessel.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Cardiac Death at 12 Month.</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Non-Cardiac Death at 12 Month.</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients That Died at 12 Months.</measure>
    <time_frame>12 months</time_frame>
    <description>The Death rate includes Cardiac- &amp; Non-Cardiac Death.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With Cardiac Death or Myocardial Infarction (MI) at 12 Month.</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Died or Had an Myocardial Infarction (MI) at 12 Month.</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Died, Had an Myocardial Infarction (MI) or a Target Vessel Revascularization (TVR) at12 Month.</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a ARC (Academic Research Consortium) Stent Thrombosis Rate at 12 Month.</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With a Stroke at 12 Month.</measure>
    <time_frame>12 months</time_frame>
    <description>The stroke rate includes: Ischemic- , Hemorraghic- &amp; Undetermined Stroke.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Periprocedural Technical Success Rate.</measure>
    <time_frame>Day 1 (periprocedure)</time_frame>
    <description>Technical Success Rate is defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization, and post-procedure diameter stenosis less then 30% in 2 near-orthogonal projections with TIMI 3 flow in the target lesion. Technical success is lesion based.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Periprocedural Clinical Procedural Success Rate</measure>
    <time_frame>Day 1 (periprocedure)</time_frame>
    <description>Procedural Success Rate is defined as post-procedure diameter less then 30% in 2 near-orthogonal projections with TIMI 3 flow in all target lesions without occurrence of in-hospital cardiac death, MI, TVR. Procedural success rate is subject based.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With a Target Lesion Failure (TLF) at 12 Month.</measure>
    <time_frame>12 month</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Patients With Revascularization (=All Revascularizations) at 12 Month.</measure>
    <time_frame>12 Month</time_frame>
    <description>All CEC adjudicated revascularization at 12 month (Intent to treat population).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1684</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Promus Element Plus</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SYNERGY</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PROMUS Element Plus</intervention_name>
    <description>A drug eluting coronary stent system</description>
    <arm_group_label>Promus Element Plus</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SYNERGY</intervention_name>
    <description>A drug eluting coronary stent system</description>
    <arm_group_label>SYNERGY</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject must be at least 18 years of age&#xD;
&#xD;
          -  Subject (or legal guardian) understands the trial requirements and the treatment&#xD;
             procedures and provides written informed consent before any trial-specific tests or&#xD;
             procedures are performed&#xD;
&#xD;
          -  For subjects less than 20 years of age enrolled at a Japanese site, the subject and&#xD;
             the subject's legal representative must provide written informed consent before any&#xD;
             study-specific tests or procedures are performed&#xD;
&#xD;
          -  Subject is eligible for percutaneous coronary intervention (PCI)&#xD;
&#xD;
          -  Subject has symptomatic coronary artery disease with objective evidence of ischemia or&#xD;
             silent ischemia&#xD;
&#xD;
          -  Subject is an acceptable candidate for coronary artery bypass grafting (CABG)&#xD;
&#xD;
          -  Subject is willing to comply with all protocol-required follow-up evaluation&#xD;
&#xD;
        Angiographic Inclusion Criteria (visual estimate):&#xD;
&#xD;
          -  Target lesion(s) must be located in a native coronary artery with a visually estimated&#xD;
             reference vessel diameter (RVD) ≥2.25 mm and ≤4.0 mm&#xD;
&#xD;
          -  Target lesion(s) length must be ≤34 mm (by visual estimate)&#xD;
&#xD;
          -  Target lesion(s) must have visually estimated stenosis ≥50% and &lt;100% with&#xD;
             thrombolysis in Myocardial Infarction (TIMI) flow &gt;1 and one of the following:&#xD;
             stenosis ≥70%, abnormal fractional flow reserve (FFR), abnormal stress or imaging&#xD;
             stress test, or elevated biomarkers prior to the procedure&#xD;
&#xD;
          -  Coronary anatomy is likely to allow delivery of a study device to the target&#xD;
             lesions(s)&#xD;
&#xD;
          -  The first lesion treated must be successfully predilated/pretreated&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with&#xD;
             acute ST elevation MI (STEMI)&#xD;
&#xD;
          -  Subject has cardiogenic shock, hemodynamic instability requiring inotropic or&#xD;
             mechanical circulatory support, intractable ventricular arrhythmias, or ongoing&#xD;
             intractable angina&#xD;
&#xD;
          -  Subject has received an organ transplant or is on a waiting list for an organ&#xD;
             transplant&#xD;
&#xD;
          -  Subject is receiving or scheduled to receive chemotherapy within 30 days before or&#xD;
             after the index procedure&#xD;
&#xD;
          -  Planned PCI (including staged procedures) or CABG after the index procedure&#xD;
&#xD;
          -  Subject previously treated at any time with intravascular brachytherapy&#xD;
&#xD;
             _ Subject has a known allergy to contrast (that cannot be adequately premedicated)&#xD;
             and/or the trial stent system or protocol-required concomitant medications (e.g.,&#xD;
             platinum, platinum-chromium alloy, stainless steel, everolimus or structurally related&#xD;
             compounds, polymer or individual components, all P2Y12 inhibitors, or aspirin)&#xD;
&#xD;
          -  Subject has one of the following (as assessed prior to the index procedure):&#xD;
&#xD;
               -  Other serious medical illness (e.g., cancer, congestive heart failure) with&#xD;
                  estimated life expectancy of less than 24 months&#xD;
&#xD;
               -  Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.)&#xD;
&#xD;
               -  Planned procedure that may cause non-compliance with the protocol or confound&#xD;
                  data interpretation&#xD;
&#xD;
          -  Subject is receiving chronic (≥72 hours) anticoagulation therapy (i.e., heparin,&#xD;
             coumadin) for indications other than acute coronary syndrome&#xD;
&#xD;
          -  Subject has a platelet count &lt;100,000 cells/mm3 or &gt;700,000 cells/mm3&#xD;
&#xD;
          -  Subject has a white blood cell (WBC) count &lt; 3,000 cells/mm3&#xD;
&#xD;
          -  Subject has documented or suspected liver disease, including laboratory evidence of&#xD;
             hepatitis&#xD;
&#xD;
          -  Subject is on dialysis or has baseline serum creatinine level &gt;2.0 mg/dL (177µmol/L)&#xD;
&#xD;
          -  Subject has a history of bleeding diathesis or coagulopathy or will refuse blood&#xD;
             transfusions&#xD;
&#xD;
          -  Subject has had a history of cerebrovascular accident (CVA) or transient ischemic&#xD;
             attack (TIA) within the past 6 months&#xD;
&#xD;
          -  Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding&#xD;
&#xD;
          -  Subject has severe symptomatic heart failure (i.e., NYHA class IV)&#xD;
&#xD;
          -  Subject is participating in another investigational drug or device clinical trial that&#xD;
             has not reached its primary endpoint&#xD;
&#xD;
          -  Subject intends to participate in another investigational drug or device clinical&#xD;
             trial within 12 months after the index procedure&#xD;
&#xD;
          -  Subject with known intention to procreate within 12 months after the index procedure&#xD;
             (women of child-bearing potential who are sexually active must agree to use a reliable&#xD;
             method of contraception from the time of screening through 12 months after the index&#xD;
             procedure)&#xD;
&#xD;
          -  Subject is a woman who is pregnant or nursing (a pregnancy test must be performed&#xD;
             within 7 days prior to the index procedure in women of child-bearing potential)&#xD;
&#xD;
        Angiographic Exclusion Criteria (visual estimate):&#xD;
&#xD;
          -  Planned treatment of more than 3 lesions&#xD;
&#xD;
          -  Planned treatment of lesions in more than 2 major epicardial vessels&#xD;
&#xD;
          -  Planned treatment of a single lesion with more than 1 stent&#xD;
&#xD;
          -  Subject has 2 target lesions in the same vessel that are separated by less than 15 mm&#xD;
             (by visual estimate)&#xD;
&#xD;
          -  Target lesion(s) is located in the left main&#xD;
&#xD;
          -  Target lesion(s) is located within 3 mm of the origin of the left anterior descending&#xD;
             (LAD) coronary artery or left circumflex (LCx) coronary artery by visual estimate&#xD;
&#xD;
          -  Target lesion(s) is located within a saphenous vein graft or an arterial graft&#xD;
&#xD;
          -  Target lesion(s) will be accessed via a saphenous vein graft or arterial graft&#xD;
&#xD;
          -  Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide&#xD;
             wire crossing&#xD;
&#xD;
          -  Target lesion(s) treated during the index procedure that involves a complex&#xD;
             bifurcation (e.g., bifurcation lesion requiring treatment with more than 1 stent)&#xD;
&#xD;
          -  Target lesion(s) is restenotic from a previous stent implantation or study stent would&#xD;
             overlap with a previous stent&#xD;
&#xD;
          -  Subject has unprotected left main coronary artery disease (&gt;50% diameter stenosis)&#xD;
&#xD;
          -  Subject has been treated with any type of PCI (i.e., balloon angioplasty, stent,&#xD;
             cutting balloon atherectomy) within 24 hours prior to the index procedure&#xD;
&#xD;
          -  Thrombus, or possible thrombus, present in the target vessel (by visual estimate)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peter M Maurer, MPH</last_name>
    <role>Study Director</role>
    <affiliation>Boston Scientific Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Baptist Medical Center - Princeton</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Banner Good Samaritan Medical Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arkansas Heart Hospital</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72211</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bakersfield Memorial Hospital</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of California Davis Health System</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95617</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sutter Memorial Hospital</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95819</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Alvarado Hospital Medical Center</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92121</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Colorado Medical Center</name>
      <address>
        <city>Greeley</city>
        <state>Colorado</state>
        <zip>80631</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Denver Cardiology Associates, PC</name>
      <address>
        <city>Littleton</city>
        <state>Colorado</state>
        <zip>80120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington Hospital Center</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20010</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Morton Plant Mease Healthcare</name>
      <address>
        <city>Clearwater</city>
        <state>Florida</state>
        <zip>33756</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Miami McKnight Brain Institute</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33138</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MediQuest</name>
      <address>
        <city>Ocala</city>
        <state>Florida</state>
        <zip>34471</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Florida Hospital Medical Center</name>
      <address>
        <city>Orlando</city>
        <state>Florida</state>
        <zip>32803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tallahassee Research Institute, Inc.</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical Center of Central Georgia</name>
      <address>
        <city>Macon</city>
        <state>Georgia</state>
        <zip>31201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wellstar Health Systems</name>
      <address>
        <city>Marietta</city>
        <state>Georgia</state>
        <zip>30060</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaiser Foundation Hospital</name>
      <address>
        <city>Honolulu</city>
        <state>Hawaii</state>
        <zip>96819</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kootenai Medical Center</name>
      <address>
        <city>Coeur d'Alene</city>
        <state>Idaho</state>
        <zip>83814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Prairie Cardiovascular Consultants, Ltd.</name>
      <address>
        <city>Springfield</city>
        <state>Illinois</state>
        <zip>62701</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern Indiana Research Alliance</name>
      <address>
        <city>Fort Wayne</city>
        <state>Indiana</state>
        <zip>46804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Vincent's Medical Group, Inc.</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46290</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Genesis Medical Center</name>
      <address>
        <city>Davenport</city>
        <state>Iowa</state>
        <zip>52803</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy Hospital Medical Center</name>
      <address>
        <city>Des Moines</city>
        <state>Iowa</state>
        <zip>50314</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kings Daughters Medical Center</name>
      <address>
        <city>Ashland</city>
        <state>Kentucky</state>
        <zip>41101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Maine Medical Center</name>
      <address>
        <city>Portland</city>
        <state>Maine</state>
        <zip>04102</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedStar Union Memorial Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tufts Medical Center, Inc.</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brigham &amp; Women's Hospital</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beth Israel Deaconess Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02215</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lahey Clinic Medical Center - Burlington</name>
      <address>
        <city>Burlington</city>
        <state>Massachusetts</state>
        <zip>01805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henry Ford Health System</name>
      <address>
        <city>Detroit</city>
        <state>Michigan</state>
        <zip>48202</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Genesys Regional Medical Center</name>
      <address>
        <city>Grand Blanc</city>
        <state>Michigan</state>
        <zip>48439</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northern Michigan Hospital</name>
      <address>
        <city>Petoskey</city>
        <state>Michigan</state>
        <zip>49770</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Mary's Duluth Clinic</name>
      <address>
        <city>Duluth</city>
        <state>Minnesota</state>
        <zip>55805</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Abbott Northwestern Hospital</name>
      <address>
        <city>Minneapolis</city>
        <state>Minnesota</state>
        <zip>55407</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Mississippi Medical Center</name>
      <address>
        <city>Tupelo</city>
        <state>Mississippi</state>
        <zip>38801</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saint Luke's Hospital of Kansas City</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64111</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University School of Medicine</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Deborah Heart and Lung Center</name>
      <address>
        <city>Browns Mills</city>
        <state>New Jersey</state>
        <zip>08015</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Our Lady of Lourdes Medical Center</name>
      <address>
        <city>Haddon Heights</city>
        <state>New Jersey</state>
        <zip>08035</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Morristown Medical Center</name>
      <address>
        <city>Morristown</city>
        <state>New Jersey</state>
        <zip>07960</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New Mexico Heart Institute, PA</name>
      <address>
        <city>Albuquerque</city>
        <state>New Mexico</state>
        <zip>87042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai - PRIME</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Columbia University Medical Center</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10032</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>New York Presbyterian Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10065</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Moses H. Cone Memorial Hospital-LeBauer Cardiovascular Research Foundation</name>
      <address>
        <city>Greensboro</city>
        <state>North Carolina</state>
        <zip>27401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rex Hospital</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Heart Research, LLC</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Wake Forest University</name>
      <address>
        <city>Winston-Salem</city>
        <state>North Carolina</state>
        <zip>27157</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lindner Center for Research and Education at Christ Hosp</name>
      <address>
        <city>Cincinnati</city>
        <state>Ohio</state>
        <zip>45219</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospitals Case Medical Center</name>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ohio State University Medical Center</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43210</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy St. Vincent Medical Center</name>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43608</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Oklahoma Heart Hospital</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73120</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Providence Portland Medical Center</name>
      <address>
        <city>Portland</city>
        <state>Oregon</state>
        <zip>97213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Geisinger Clinic</name>
      <address>
        <city>Danville</city>
        <state>Pennsylvania</state>
        <zip>17822</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pennsylvania Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19107</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Temple University Hospital</name>
      <address>
        <city>Philadelphia</city>
        <state>Pennsylvania</state>
        <zip>19140</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sisters of Charity Providence Hospitals</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jackson Madison County Hospital</name>
      <address>
        <city>Jackson</city>
        <state>Tennessee</state>
        <zip>38301</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centennial Medical Center</name>
      <address>
        <city>Nashville</city>
        <state>Tennessee</state>
        <zip>37203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baylor Heart &amp; Vascular Hospital</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75226</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medical City Dallas Hospital</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75230</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. David's Round Rock Medical Center</name>
      <address>
        <city>Round Rock</city>
        <state>Texas</state>
        <zip>78681</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist Texsan Hospital</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78201</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Henrico Doctors Hospital</name>
      <address>
        <city>Richmond</city>
        <state>Virginia</state>
        <zip>23229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Swedish Medical Center</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98122</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Aspirus Heart &amp; Vascular Institute</name>
      <address>
        <city>Wausau</city>
        <state>Wisconsin</state>
        <zip>54401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Prince Charles Hospital</name>
      <address>
        <city>Chermside</city>
        <state>Queensland</state>
        <zip>4032</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Monash Medical Centre-Clayton Campus</name>
      <address>
        <city>Clayton</city>
        <state>Victoria</state>
        <zip>3168</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Vincent's Hospital Melbourne</name>
      <address>
        <city>Fitzroy</city>
        <state>Victoria</state>
        <zip>3065</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Fremantle Hospital</name>
      <address>
        <city>Fremantle</city>
        <state>Western Australia</state>
        <zip>6160</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>LKH - Universitätsklinikum der PMU Salzburg</name>
      <address>
        <city>Salzburg</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AKH - Medizinische Universität Wien</name>
      <address>
        <city>Vienna</city>
        <country>Austria</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Imelda Ziekenhuis</name>
      <address>
        <city>Bonheiden</city>
        <zip>2820</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Z.O.L - Campus St. Jan</name>
      <address>
        <city>Genk</city>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>HHrm</name>
      <address>
        <city>Roeselare</city>
        <zip>8800</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Foothills Medical Centre</name>
      <address>
        <city>Calgary</city>
        <state>Alberta</state>
        <zip>T2N 2T9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hamilton Health Sciences</name>
      <address>
        <city>Hamilton</city>
        <state>Ontario</state>
        <zip>L8L 2X2</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M4</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut de Cardiologie de Montreal</name>
      <address>
        <city>Montreal</city>
        <state>Quebec</state>
        <zip>H1T 1C8</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Institut Universitaire de Cardiologie et de Pneumologie de Quebec</name>
      <address>
        <city>Sainte-Foy</city>
        <state>Quebec</state>
        <zip>G1V 4G5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rigshospitalet Copenhagen</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital, Heart Centre</name>
      <address>
        <city>Tampere</city>
        <zip>33521</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Turku University Hospital</name>
      <address>
        <city>Turku</city>
        <zip>FI-20520</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Brest - Hôpital de la Cavale Blanche</name>
      <address>
        <city>Brest Cedex 2</city>
        <state>Finistere</state>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Toulouse - Hôpital Rangueil</name>
      <address>
        <city>Toulouse</city>
        <state>Haute Garonne</state>
        <zip>31059</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Pasteur - Toulouse</name>
      <address>
        <city>Toulouse</city>
        <state>Haute Garonne</state>
        <zip>31076</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel</name>
      <address>
        <city>Bron</city>
        <state>Rhone</state>
        <zip>69500</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinique Saint-Hilaire - Centre Frédéric Joliot</name>
      <address>
        <city>Rouen</city>
        <state>Seine Maritime</state>
        <zip>76000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Polyclinique Les Fleurs</name>
      <address>
        <city>Ollioules</city>
        <state>Var</state>
        <zip>83192</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier de Lagny - Marne La Vallée</name>
      <address>
        <city>Lagny-sur-Marne cedex</city>
        <zip>77600</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Cochin</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Istituto Clinico Humanitas</name>
      <address>
        <city>Rozzano</city>
        <state>Milano</state>
        <zip>20089</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Umberto I Pol. di Roma-Università di Roma La Sapienza</name>
      <address>
        <city>Roma</city>
        <zip>161</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Città della Salute e della Scienza di Torino</name>
      <address>
        <city>Torino</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kokura Memorial Hospital</name>
      <address>
        <city>Kitakyushu-shi</city>
        <state>Fukuoka-Ken</state>
        <zip>802-8555</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kurume University Hospital</name>
      <address>
        <city>Kurume-shi</city>
        <state>Fukuoka-Ken</state>
        <zip>830-0011</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Saiseikai Yokohamashi Tobu Hospital</name>
      <address>
        <city>Yokohama-shi</city>
        <state>Kanagawa-Ken</state>
        <zip>230-8765</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Shonan Kamakura General Hospital</name>
      <address>
        <city>Kamakura-shi</city>
        <state>Kanagawa</state>
        <zip>247-8533</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kyoto University Hospital</name>
      <address>
        <city>Kyoto-shi</city>
        <state>Kyoto-Fu</state>
        <zip>606-8507</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Cerebral and Cardiovascular Center</name>
      <address>
        <city>Suita-shi</city>
        <state>Osaka-Fu</state>
        <zip>565-8565</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teikyo University Hospital</name>
      <address>
        <city>Itabashi-ku</city>
        <state>Tokyo-To</state>
        <zip>173-8606</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nihon University Itabashi Hospital</name>
      <address>
        <city>Itabashi-ku</city>
        <state>Tokyo-To</state>
        <zip>173-8610</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Toho University Ohashi Medical Center</name>
      <address>
        <city>Meguro-ku</city>
        <state>Tokyo-To</state>
        <zip>153-8515</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Cardiovascular Institute</name>
      <address>
        <city>Minato-ku</city>
        <state>Tokyo-To</state>
        <zip>106-0031</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Showa University Hospital</name>
      <address>
        <city>Shinagawa-ku</city>
        <state>Tokyo-To</state>
        <zip>142-8666</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Cardiology, Tokyo Women's Medical University</name>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo-To</state>
        <zip>162-8666</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>P. Stradins Clinical University Hospital</name>
      <address>
        <city>Riga</city>
        <zip>LV1002</zip>
        <country>Latvia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medisch Centrum Alkmaar</name>
      <address>
        <city>Alkmaar</city>
        <zip>1815 JD</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medisch Spectrum Twente, Haaksbergerstraat</name>
      <address>
        <city>Enschede</city>
        <zip>7513 ER</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Antonius Ziekenhuis, Nieuwegein</name>
      <address>
        <city>Nieuwegein</city>
        <zip>3435CM</zip>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ascot Angiography Ltd</name>
      <address>
        <city>Auckland</city>
        <zip>1050</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Middlemore Hospital</name>
      <address>
        <city>Auckland</city>
        <zip>1640</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Shore Hospital</name>
      <address>
        <city>Auckland</city>
        <zip>622</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christchurch Hospital NZ</name>
      <address>
        <city>Christchurch</city>
        <zip>8011</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SPZOZ Szpital Uniwersytecki w Krakowie</name>
      <address>
        <city>Krakow</city>
        <zip>31-501</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>SK Przemienienia Panskiego UM im.K.Marcinkowskiego</name>
      <address>
        <city>Poznan</city>
        <zip>61-848</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Instytut Kardiologii im.Prymasa Tysiaclecia Kardynala Stefana Wyszynskiego</name>
      <address>
        <city>Warszawa</city>
        <zip>04-628</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National University Hospital</name>
      <address>
        <city>Singapore</city>
        <zip>119228</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Heart Centre</name>
      <address>
        <city>Singapore</city>
        <zip>168752</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <zip>8036</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Clínico San Carlos</name>
      <address>
        <city>Madrid</city>
        <zip>28040</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Canada</country>
    <country>Denmark</country>
    <country>Finland</country>
    <country>France</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Latvia</country>
    <country>Netherlands</country>
    <country>New Zealand</country>
    <country>Poland</country>
    <country>Singapore</country>
    <country>Spain</country>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2012</study_first_posted>
  <results_first_submitted>December 1, 2015</results_first_submitted>
  <results_first_submitted_qc>December 1, 2015</results_first_submitted_qc>
  <results_first_posted type="Estimate">January 7, 2016</results_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 30, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Drug-Eluting Stents</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>A total of 1684 patients have been enrolled in the study Evolve II Randomizes Clinical trial (RCT) from 26 November 2012 until 29 Aug 2013.&#xD;
The Evolve II RCT study is anticipated to be completed (final 5-year follow-up) in 2018.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Promus Element Plus</title>
          <description>PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).&#xD;
PROMUS Element Plus: A drug eluting coronary stent system</description>
        </group>
        <group group_id="P2">
          <title>SYNERGY</title>
          <description>SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).&#xD;
SYNERGY: A drug eluting coronary stent system</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="838"/>
                <participants group_id="P2" count="846"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed 12-Month Clinical F/U</title>
              <participants_list>
                <participants group_id="P1" count="797"/>
                <participants group_id="P2" count="822"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>No 12-Month F/U</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Death With No 12-month Clinical FU</title>
              <participants_list>
                <participants group_id="P1" count="9"/>
                <participants group_id="P2" count="9"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="806"/>
                <participants group_id="P2" count="831"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="32"/>
                <participants group_id="P2" count="15"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Promus Element Plus</title>
          <description>PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).&#xD;
PROMUS Element Plus: A drug eluting coronary stent system</description>
        </group>
        <group group_id="B2">
          <title>SYNERGY</title>
          <description>SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).&#xD;
SYNERGY: A drug eluting coronary stent system</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="838"/>
            <count group_id="B2" value="846"/>
            <count group_id="B3" value="1684"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>yr</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="63.92" spread="10.50"/>
                    <measurement group_id="B2" value="63.48" spread="10.44"/>
                    <measurement group_id="B3" value="63.70" spread="10.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="229"/>
                    <measurement group_id="B2" value="249"/>
                    <measurement group_id="B3" value="478"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="609"/>
                    <measurement group_id="B2" value="597"/>
                    <measurement group_id="B3" value="1206"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <description>The Ethnicity and Race data are not mutually exclusive. For example: subject can check both &quot;Asian&quot; and &quot;Native Hawaiian or other Pacific Islander&quot;, or &quot;Caucasian&quot; and &quot;Hispanic or Latino&quot;.&#xD;
Therefore the sum of participants in all Categories for the Measure does not equal the Overall Number of Baseline Participants in the Arm/Group</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>American Indian or Alaska native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="100"/>
                    <measurement group_id="B2" value="100"/>
                    <measurement group_id="B3" value="200"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black,of African heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="37"/>
                    <measurement group_id="B2" value="52"/>
                    <measurement group_id="B3" value="89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="664"/>
                    <measurement group_id="B2" value="655"/>
                    <measurement group_id="B3" value="1319"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or other Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Disclosed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Singapore</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="15"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="506"/>
                    <measurement group_id="B2" value="514"/>
                    <measurement group_id="B3" value="1020"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Japan</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="81"/>
                    <measurement group_id="B2" value="74"/>
                    <measurement group_id="B3" value="155"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Spain</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="18"/>
                    <measurement group_id="B3" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>New Zealand</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Canada</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                    <measurement group_id="B2" value="58"/>
                    <measurement group_id="B3" value="114"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Latvia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Netherlands</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Austria</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Belgium</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="50"/>
                    <measurement group_id="B2" value="50"/>
                    <measurement group_id="B3" value="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Finland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="16"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Denmark</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="10"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Poland</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="4"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Italy</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>France</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="23"/>
                    <measurement group_id="B3" value="43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Height</title>
          <units>inches</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="67.44" spread="4.07"/>
                    <measurement group_id="B2" value="67.23" spread="4.00"/>
                    <measurement group_id="B3" value="67.33" spread="4.04"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Weight</title>
          <units>lbs</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="190.45" spread="44.29"/>
                    <measurement group_id="B2" value="190.92" spread="44.09"/>
                    <measurement group_id="B3" value="190.69" spread="44.18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Smoking, Ever</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="519"/>
                    <measurement group_id="B2" value="510"/>
                    <measurement group_id="B3" value="1029"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Smoking,Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="12"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Smoking, Never</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="307"/>
                    <measurement group_id="B2" value="317"/>
                    <measurement group_id="B3" value="624"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Current Diabetes Mellitus</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Current Diabetes Mellitus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="276"/>
                    <measurement group_id="B2" value="275"/>
                    <measurement group_id="B3" value="551"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No Current Diabetes Mellitus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="562"/>
                    <measurement group_id="B2" value="571"/>
                    <measurement group_id="B3" value="1133"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hyperlipidemia Requiring Medication</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Hyperlipidemia Requiring Medication</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="621"/>
                    <measurement group_id="B2" value="625"/>
                    <measurement group_id="B3" value="1246"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No Hyperlipidemia requiring Medication</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="217"/>
                    <measurement group_id="B2" value="221"/>
                    <measurement group_id="B3" value="438"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Hypertension Requiring Medication</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Hypertension requiring medication</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="629"/>
                    <measurement group_id="B2" value="652"/>
                    <measurement group_id="B3" value="1281"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No Hypertension requiring medication</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="209"/>
                    <measurement group_id="B2" value="194"/>
                    <measurement group_id="B3" value="403"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>History of bleeding disorder</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Hystory of bleeding disorder</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No history of bleeding disorder</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="837"/>
                    <measurement group_id="B2" value="844"/>
                    <measurement group_id="B3" value="1681"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>History of GI bleeding</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>History of GI Bleeding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No History of GI Bleeding</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="838"/>
                    <measurement group_id="B2" value="844"/>
                    <measurement group_id="B3" value="1682"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>History of Transient Ischemic Attack</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>History of Transient Ischemic Attack</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No History of Transient Ischemic Attack</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="815"/>
                    <measurement group_id="B2" value="822"/>
                    <measurement group_id="B3" value="1637"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>History of cerebrovascular accident</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>History of Cerebrovascular Accident</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                    <measurement group_id="B2" value="30"/>
                    <measurement group_id="B3" value="62"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No History of Cerebrovascular Accident</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="806"/>
                    <measurement group_id="B2" value="816"/>
                    <measurement group_id="B3" value="1622"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>History of Transient Ischemic Attack (TIA) or Cerebrovasular Accident (CVA)</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>History of TIA or CVA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                    <measurement group_id="B2" value="48"/>
                    <measurement group_id="B3" value="97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No history of TIA or CVA</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="789"/>
                    <measurement group_id="B2" value="798"/>
                    <measurement group_id="B3" value="1587"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>History of peripheral vascular disease (PVD)</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>History of PVD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="59"/>
                    <measurement group_id="B2" value="68"/>
                    <measurement group_id="B3" value="127"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No History of PVD</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="779"/>
                    <measurement group_id="B2" value="778"/>
                    <measurement group_id="B3" value="1557"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>History of renal disease</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>History of renal disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="52"/>
                    <measurement group_id="B2" value="56"/>
                    <measurement group_id="B3" value="108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>No History of renal disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="786"/>
                    <measurement group_id="B2" value="790"/>
                    <measurement group_id="B3" value="1576"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Baseline Lesion Characteristics as determined by the Angiographic Core Laboratory, ITT Analysis Set</title>
          <description>The Promus Element Plus group has 1043 lesions in 838 subjects enrolled in this treatment arm.&#xD;
The Synergy group has 1059 lesions in 846 subjects enrolled in this treatment arm.&#xD;
The measure type is number of lesions. The total number of lesions does not match with the total number of participants since some of the participants have more than one lesion.</description>
          <units>Number of lesions</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Left Anterior Descending (LAD)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="433"/>
                    <measurement group_id="B2" value="437"/>
                    <measurement group_id="B3" value="870"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Left Circumflex Artery (LCx)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="275"/>
                    <measurement group_id="B2" value="265"/>
                    <measurement group_id="B3" value="540"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Right Coronary Artery (RCA)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="334"/>
                    <measurement group_id="B2" value="357"/>
                    <measurement group_id="B3" value="691"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Left Main Coronary Artery (LMCA)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Percentage of Participants With Target Lesion Failure (TLF) at 12 Months</title>
        <description>TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death.</description>
        <time_frame>12 months</time_frame>
        <population>The per protocol population was used for this analysis. Therefore the number of participants analyzed is not consistent with the numbers provided in participant flow module.</population>
        <group_list>
          <group group_id="O1">
            <title>Promus Element Plus</title>
            <description>PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).&#xD;
PROMUS Element Plus: A drug eluting coronary stent system</description>
          </group>
          <group group_id="O2">
            <title>SYNERGY</title>
            <description>SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).&#xD;
SYNERGY: A drug eluting coronary stent system</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Target Lesion Failure (TLF) at 12 Months</title>
          <description>TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death.</description>
          <population>The per protocol population was used for this analysis. Therefore the number of participants analyzed is not consistent with the numbers provided in participant flow module.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="796"/>
                <count group_id="O2" value="823"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.4"/>
                    <measurement group_id="O2" value="6.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Target Lesion Revascularization (TLR) at 12 Months.</title>
        <description>The TLR overall rate includes: TLR Percutaneous Coronary Intervention (PCI) &amp; TLR Coronary Artery Bypass Graft (CABG).</description>
        <time_frame>12 months</time_frame>
        <population>Intent-to-Treat population</population>
        <group_list>
          <group group_id="O1">
            <title>Promus Element Plus</title>
            <description>PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).&#xD;
PROMUS Element Plus: A drug eluting coronary stent system</description>
          </group>
          <group group_id="O2">
            <title>SYNERGY</title>
            <description>SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).&#xD;
SYNERGY: A drug eluting coronary stent system</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Target Lesion Revascularization (TLR) at 12 Months.</title>
          <description>The TLR overall rate includes: TLR Percutaneous Coronary Intervention (PCI) &amp; TLR Coronary Artery Bypass Graft (CABG).</description>
          <population>Intent-to-Treat population</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="808"/>
                <count group_id="O2" value="832"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.7"/>
                    <measurement group_id="O2" value="2.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Target Vessel Revascularization (TVR) at 12 Months.</title>
        <description>TVR overall includes: TVR PCI &amp; TVR CABG.</description>
        <time_frame>12 months</time_frame>
        <population>Intent-to- Treat</population>
        <group_list>
          <group group_id="O1">
            <title>Promus Element Plus</title>
            <description>PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).&#xD;
PROMUS Element Plus: A drug eluting coronary stent system</description>
          </group>
          <group group_id="O2">
            <title>SYNERGY</title>
            <description>SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).&#xD;
SYNERGY: A drug eluting coronary stent system</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Target Vessel Revascularization (TVR) at 12 Months.</title>
          <description>TVR overall includes: TVR PCI &amp; TVR CABG.</description>
          <population>Intent-to- Treat</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="808"/>
                <count group_id="O2" value="832"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6"/>
                    <measurement group_id="O2" value="3.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Target Vessel Failure (TVF) at 12 Month.</title>
        <description>Target Vessel Failure is defined as any ischemic-driven revascularization of the target vessel, MI related to the target vessel, or any cardiac death.</description>
        <time_frame>12 months</time_frame>
        <population>Intent-to-treat analysis</population>
        <group_list>
          <group group_id="O1">
            <title>Promus Element Plus</title>
            <description>PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).&#xD;
PROMUS Element Plus: A drug eluting coronary stent system</description>
          </group>
          <group group_id="O2">
            <title>SYNERGY</title>
            <description>SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).&#xD;
SYNERGY: A drug eluting coronary stent system</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Target Vessel Failure (TVF) at 12 Month.</title>
          <description>Target Vessel Failure is defined as any ischemic-driven revascularization of the target vessel, MI related to the target vessel, or any cardiac death.</description>
          <population>Intent-to-treat analysis</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="808"/>
                <count group_id="O2" value="832"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.2"/>
                    <measurement group_id="O2" value="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Myocardial Infarction at 12 Month.</title>
        <description>The MI rate includes: MI's related to the Target Vessel, MI's with unknown relationship to the Target Vessel and MI's not related to the Target Vessel.</description>
        <time_frame>12 months</time_frame>
        <population>Intent-to-treat</population>
        <group_list>
          <group group_id="O1">
            <title>Promus Element Plus</title>
            <description>PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).&#xD;
PROMUS Element Plus: A drug eluting coronary stent system</description>
          </group>
          <group group_id="O2">
            <title>SYNERGY</title>
            <description>SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).&#xD;
SYNERGY: A drug eluting coronary stent system</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Myocardial Infarction at 12 Month.</title>
          <description>The MI rate includes: MI's related to the Target Vessel, MI's with unknown relationship to the Target Vessel and MI's not related to the Target Vessel.</description>
          <population>Intent-to-treat</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="808"/>
                <count group_id="O2" value="832"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.0"/>
                    <measurement group_id="O2" value="5.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Cardiac Death at 12 Month.</title>
        <time_frame>12 months</time_frame>
        <population>Intent-to-treat population</population>
        <group_list>
          <group group_id="O1">
            <title>Promus Element Plus</title>
            <description>PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).&#xD;
PROMUS Element Plus: A drug eluting coronary stent system</description>
          </group>
          <group group_id="O2">
            <title>SYNERGY</title>
            <description>SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).&#xD;
SYNERGY: A drug eluting coronary stent system</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Cardiac Death at 12 Month.</title>
          <population>Intent-to-treat population</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="808"/>
                <count group_id="O2" value="832"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9"/>
                    <measurement group_id="O2" value="0.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With Non-Cardiac Death at 12 Month.</title>
        <time_frame>12 months</time_frame>
        <population>Intent-to-treat population</population>
        <group_list>
          <group group_id="O1">
            <title>Promus Element Plus</title>
            <description>PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).&#xD;
PROMUS Element Plus: A drug eluting coronary stent system</description>
          </group>
          <group group_id="O2">
            <title>SYNERGY</title>
            <description>SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).&#xD;
SYNERGY: A drug eluting coronary stent system</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With Non-Cardiac Death at 12 Month.</title>
          <population>Intent-to-treat population</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="808"/>
                <count group_id="O2" value="832"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.2"/>
                    <measurement group_id="O2" value="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients That Died at 12 Months.</title>
        <description>The Death rate includes Cardiac- &amp; Non-Cardiac Death.</description>
        <time_frame>12 months</time_frame>
        <population>Intent-to-treat population</population>
        <group_list>
          <group group_id="O1">
            <title>Promus Element Plus</title>
            <description>PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).&#xD;
PROMUS Element Plus: A drug eluting coronary stent system</description>
          </group>
          <group group_id="O2">
            <title>SYNERGY</title>
            <description>SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).&#xD;
SYNERGY: A drug eluting coronary stent system</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients That Died at 12 Months.</title>
          <description>The Death rate includes Cardiac- &amp; Non-Cardiac Death.</description>
          <population>Intent-to-treat population</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="808"/>
                <count group_id="O2" value="832"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.1"/>
                    <measurement group_id="O2" value="1.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With Cardiac Death or Myocardial Infarction (MI) at 12 Month.</title>
        <time_frame>12 months</time_frame>
        <population>Intent-to-treat population</population>
        <group_list>
          <group group_id="O1">
            <title>Promus Element Plus</title>
            <description>PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).&#xD;
PROMUS Element Plus: A drug eluting coronary stent system</description>
          </group>
          <group group_id="O2">
            <title>SYNERGY</title>
            <description>SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).&#xD;
SYNERGY: A drug eluting coronary stent system</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Cardiac Death or Myocardial Infarction (MI) at 12 Month.</title>
          <population>Intent-to-treat population</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="808"/>
                <count group_id="O2" value="832"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.6"/>
                    <measurement group_id="O2" value="5.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Died or Had an Myocardial Infarction (MI) at 12 Month.</title>
        <time_frame>12 months</time_frame>
        <population>Intent-to-treat population</population>
        <group_list>
          <group group_id="O1">
            <title>Promus Element Plus</title>
            <description>PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).&#xD;
PROMUS Element Plus: A drug eluting coronary stent system</description>
          </group>
          <group group_id="O2">
            <title>SYNERGY</title>
            <description>SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).&#xD;
SYNERGY: A drug eluting coronary stent system</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Died or Had an Myocardial Infarction (MI) at 12 Month.</title>
          <population>Intent-to-treat population</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="808"/>
                <count group_id="O2" value="832"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5.8"/>
                    <measurement group_id="O2" value="6.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants Who Died, Had an Myocardial Infarction (MI) or a Target Vessel Revascularization (TVR) at12 Month.</title>
        <time_frame>12 months</time_frame>
        <population>Intent-to-treat population</population>
        <group_list>
          <group group_id="O1">
            <title>Promus Element Plus</title>
            <description>PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).&#xD;
PROMUS Element Plus: A drug eluting coronary stent system</description>
          </group>
          <group group_id="O2">
            <title>SYNERGY</title>
            <description>SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).&#xD;
SYNERGY: A drug eluting coronary stent system</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants Who Died, Had an Myocardial Infarction (MI) or a Target Vessel Revascularization (TVR) at12 Month.</title>
          <population>Intent-to-treat population</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="808"/>
                <count group_id="O2" value="832"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8.4"/>
                    <measurement group_id="O2" value="9.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a ARC (Academic Research Consortium) Stent Thrombosis Rate at 12 Month.</title>
        <time_frame>12 months</time_frame>
        <population>Intent-to-treat population.</population>
        <group_list>
          <group group_id="O1">
            <title>Promus Element Plus</title>
            <description>PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).&#xD;
PROMUS Element Plus: A drug eluting coronary stent system</description>
          </group>
          <group group_id="O2">
            <title>SYNERGY</title>
            <description>SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).&#xD;
SYNERGY: A drug eluting coronary stent system</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a ARC (Academic Research Consortium) Stent Thrombosis Rate at 12 Month.</title>
          <population>Intent-to-treat population.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="808"/>
                <count group_id="O2" value="832"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.7"/>
                    <measurement group_id="O2" value="0.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With a Stroke at 12 Month.</title>
        <description>The stroke rate includes: Ischemic- , Hemorraghic- &amp; Undetermined Stroke.</description>
        <time_frame>12 months</time_frame>
        <population>Intent-to-Treat population.</population>
        <group_list>
          <group group_id="O1">
            <title>Promus Element Plus</title>
            <description>PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).&#xD;
PROMUS Element Plus: A drug eluting coronary stent system</description>
          </group>
          <group group_id="O2">
            <title>SYNERGY</title>
            <description>SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).&#xD;
SYNERGY: A drug eluting coronary stent system</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With a Stroke at 12 Month.</title>
          <description>The stroke rate includes: Ischemic- , Hemorraghic- &amp; Undetermined Stroke.</description>
          <population>Intent-to-Treat population.</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="808"/>
                <count group_id="O2" value="832"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.9"/>
                    <measurement group_id="O2" value="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Periprocedural Technical Success Rate.</title>
        <description>Technical Success Rate is defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization, and post-procedure diameter stenosis less then 30% in 2 near-orthogonal projections with TIMI 3 flow in the target lesion. Technical success is lesion based.</description>
        <time_frame>Day 1 (periprocedure)</time_frame>
        <population>Intent-to-Treat analysis set. Promus Element Plus population: 838 subject analyzed with 1043 lesions treated with technical success achieved in 1011 lesions.&#xD;
SYNERGY population: 846 subjects analyzed with 1059 lesions treated with technical success achieved in 1041 lesions.</population>
        <group_list>
          <group group_id="O1">
            <title>Promus Element Plus</title>
            <description>PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).&#xD;
PROMUS Element Plus: A drug eluting coronary stent system</description>
          </group>
          <group group_id="O2">
            <title>SYNERGY</title>
            <description>SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).&#xD;
SYNERGY: A drug eluting coronary stent system</description>
          </group>
        </group_list>
        <measure>
          <title>Periprocedural Technical Success Rate.</title>
          <description>Technical Success Rate is defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization, and post-procedure diameter stenosis less then 30% in 2 near-orthogonal projections with TIMI 3 flow in the target lesion. Technical success is lesion based.</description>
          <population>Intent-to-Treat analysis set. Promus Element Plus population: 838 subject analyzed with 1043 lesions treated with technical success achieved in 1011 lesions.&#xD;
SYNERGY population: 846 subjects analyzed with 1059 lesions treated with technical success achieved in 1041 lesions.</population>
          <units>percentage of lesions</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="838"/>
                <count group_id="O2" value="846"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="96.9"/>
                    <measurement group_id="O2" value="98.3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Periprocedural Clinical Procedural Success Rate</title>
        <description>Procedural Success Rate is defined as post-procedure diameter less then 30% in 2 near-orthogonal projections with TIMI 3 flow in all target lesions without occurrence of in-hospital cardiac death, MI, TVR. Procedural success rate is subject based.</description>
        <time_frame>Day 1 (periprocedure)</time_frame>
        <population>Intent-to-Treat population</population>
        <group_list>
          <group group_id="O1">
            <title>Promus Element Plus</title>
            <description>PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).&#xD;
PROMUS Element Plus: A drug eluting coronary stent system</description>
          </group>
          <group group_id="O2">
            <title>SYNERGY</title>
            <description>SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).&#xD;
SYNERGY: A drug eluting coronary stent system</description>
          </group>
        </group_list>
        <measure>
          <title>Periprocedural Clinical Procedural Success Rate</title>
          <description>Procedural Success Rate is defined as post-procedure diameter less then 30% in 2 near-orthogonal projections with TIMI 3 flow in all target lesions without occurrence of in-hospital cardiac death, MI, TVR. Procedural success rate is subject based.</description>
          <population>Intent-to-Treat population</population>
          <units>percentage of subjects</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="838"/>
                <count group_id="O2" value="846"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="94.3"/>
                    <measurement group_id="O2" value="94.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Participants With a Target Lesion Failure (TLF) at 12 Month.</title>
        <time_frame>12 month</time_frame>
        <population>Intent-to-Treat population</population>
        <group_list>
          <group group_id="O1">
            <title>Promus Element Plus</title>
            <description>PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).&#xD;
PROMUS Element Plus: A drug eluting coronary stent system</description>
          </group>
          <group group_id="O2">
            <title>SYNERGY</title>
            <description>SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).&#xD;
SYNERGY: A drug eluting coronary stent system</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Participants With a Target Lesion Failure (TLF) at 12 Month.</title>
          <population>Intent-to-Treat population</population>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="808"/>
                <count group_id="O2" value="832"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.4"/>
                    <measurement group_id="O2" value="6.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percentage of Patients With Revascularization (=All Revascularizations) at 12 Month.</title>
        <description>All CEC adjudicated revascularization at 12 month (Intent to treat population).</description>
        <time_frame>12 Month</time_frame>
        <population>Intent to treat population</population>
        <group_list>
          <group group_id="O1">
            <title>Promus Element Plus</title>
            <description>PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).&#xD;
PROMUS Element Plus: A drug eluting coronary stent system</description>
          </group>
          <group group_id="O2">
            <title>SYNERGY</title>
            <description>SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).&#xD;
SYNERGY: A drug eluting coronary stent system</description>
          </group>
        </group_list>
        <measure>
          <title>Percentage of Patients With Revascularization (=All Revascularizations) at 12 Month.</title>
          <description>All CEC adjudicated revascularization at 12 month (Intent to treat population).</description>
          <population>Intent to treat population</population>
          <units>percentage of patients</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="808"/>
                <count group_id="O2" value="832"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.6"/>
                    <measurement group_id="O2" value="4.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Site-Reported Serious Adverse Events to 12 Months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Promus Element Plus</title>
          <description>PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).&#xD;
PROMUS Element Plus: A drug eluting coronary stent system</description>
        </group>
        <group group_id="E2">
          <title>SYNERGY</title>
          <description>SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).&#xD;
SYNERGY: A drug eluting coronary stent system</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="262" subjects_at_risk="838"/>
                <counts group_id="E2" subjects_affected="265" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Blood and lymphatic system disorders</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="838"/>
                <counts group_id="E2" subjects_affected="13" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Cardiac disorders</sub_title>
                <counts group_id="E1" subjects_affected="126" subjects_at_risk="838"/>
                <counts group_id="E2" subjects_affected="143" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Congenital, familial and genetic disorders</title>
            <event_list>
              <event>
                <sub_title>Congenital, familial and genetic disorders</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="838"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Ear and labyrinth disorders</title>
            <event_list>
              <event>
                <sub_title>Ear and labyrinth disorders</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="838"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Endocrine disorders</title>
            <event_list>
              <event>
                <sub_title>Endocrine disorders</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="838"/>
                <counts group_id="E2" subjects_affected="2" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Eye disorders</title>
            <event_list>
              <event>
                <sub_title>Eye disorders</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="838"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gastrointestinal disorders</sub_title>
                <counts group_id="E1" subjects_affected="28" subjects_at_risk="838"/>
                <counts group_id="E2" subjects_affected="15" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>General disorders and administration site conditions</sub_title>
                <counts group_id="E1" subjects_affected="49" subjects_at_risk="838"/>
                <counts group_id="E2" subjects_affected="45" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Hepatobiliary disorders</title>
            <event_list>
              <event>
                <sub_title>Hepatobiliary disorders</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="838"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Immune system disorders</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="838"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Infections and infestations</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="838"/>
                <counts group_id="E2" subjects_affected="22" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Injury, poisining and procedural complications</sub_title>
                <counts group_id="E1" subjects_affected="23" subjects_at_risk="838"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Investigations</sub_title>
                <counts group_id="E1" subjects_affected="5" subjects_at_risk="838"/>
                <counts group_id="E2" subjects_affected="4" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Metabolism and nutrition disorders</sub_title>
                <counts group_id="E1" subjects_affected="7" subjects_at_risk="838"/>
                <counts group_id="E2" subjects_affected="8" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Musculoskeletal and connective tissue disorders</sub_title>
                <counts group_id="E1" subjects_affected="11" subjects_at_risk="838"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</sub_title>
                <counts group_id="E1" subjects_affected="14" subjects_at_risk="838"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Nervous sysytem disorders</sub_title>
                <counts group_id="E1" subjects_affected="18" subjects_at_risk="838"/>
                <counts group_id="E2" subjects_affected="26" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Psychiatric disorders</title>
            <event_list>
              <event>
                <sub_title>Psychiatric disorders</sub_title>
                <counts group_id="E1" subjects_affected="4" subjects_at_risk="838"/>
                <counts group_id="E2" subjects_affected="6" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal and Urinary disorders</sub_title>
                <counts group_id="E1" subjects_affected="15" subjects_at_risk="838"/>
                <counts group_id="E2" subjects_affected="14" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Reproductive system and breast disorders</title>
            <event_list>
              <event>
                <sub_title>Reproductive system and breast disorders</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="838"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory, thoracic and mediastinal disorders</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="838"/>
                <counts group_id="E2" subjects_affected="23" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Skin and subcutaneous tissue disorders</sub_title>
                <counts group_id="E1" subjects_affected="2" subjects_at_risk="838"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Surgical and medical procedures</title>
            <event_list>
              <event>
                <sub_title>Surgical and medical procedures</sub_title>
                <counts group_id="E1" subjects_affected="1" subjects_at_risk="838"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Vascular disorders</sub_title>
                <counts group_id="E1" subjects_affected="20" subjects_at_risk="838"/>
                <counts group_id="E2" subjects_affected="19" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="576" subjects_at_risk="838"/>
                <counts group_id="E2" subjects_affected="567" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Blood and lymphatic system disorders</title>
            <event_list>
              <event>
                <sub_title>Anaemia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="838"/>
                <counts group_id="E2" events="11" subjects_affected="9" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina Pectoris</sub_title>
                <counts group_id="E1" events="125" subjects_affected="104" subjects_at_risk="838"/>
                <counts group_id="E2" events="116" subjects_affected="100" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="70" subjects_affected="70" subjects_at_risk="838"/>
                <counts group_id="E2" events="74" subjects_affected="74" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Coronary artery dissection</sub_title>
                <counts group_id="E1" events="28" subjects_affected="27" subjects_at_risk="838"/>
                <counts group_id="E2" events="33" subjects_affected="32" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="19" subjects_affected="18" subjects_at_risk="838"/>
                <counts group_id="E2" events="24" subjects_affected="20" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="838"/>
                <counts group_id="E2" events="17" subjects_affected="17" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="17" subjects_affected="16" subjects_at_risk="838"/>
                <counts group_id="E2" events="15" subjects_affected="13" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <counts group_id="E1" events="13" subjects_affected="10" subjects_at_risk="838"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="838"/>
                <counts group_id="E2" events="10" subjects_affected="8" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Palpitations</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="838"/>
                <counts group_id="E2" events="7" subjects_affected="7" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="838"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="16" subjects_affected="16" subjects_at_risk="838"/>
                <counts group_id="E2" events="12" subjects_affected="12" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Gastrointestinal haemorrhage</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="838"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Abdominal pain</sub_title>
                <counts group_id="E1" events="10" subjects_affected="9" subjects_at_risk="838"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Rectal Haemorrhage</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="838"/>
                <counts group_id="E2" events="3" subjects_affected="3" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Immune system disorders</title>
            <event_list>
              <event>
                <sub_title>Drug hypersensitivity</sub_title>
                <counts group_id="E1" events="14" subjects_affected="14" subjects_at_risk="838"/>
                <counts group_id="E2" events="16" subjects_affected="15" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="15" subjects_affected="15" subjects_at_risk="838"/>
                <counts group_id="E2" events="17" subjects_affected="17" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Urinary tract infection</sub_title>
                <counts group_id="E1" events="12" subjects_affected="11" subjects_at_risk="838"/>
                <counts group_id="E2" events="12" subjects_affected="10" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Nasopharyngitis</sub_title>
                <counts group_id="E1" events="13" subjects_affected="11" subjects_at_risk="838"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Contusion</sub_title>
                <counts group_id="E1" events="18" subjects_affected="18" subjects_at_risk="838"/>
                <counts group_id="E2" events="13" subjects_affected="12" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Cardiac enzymes increased</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="838"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Troponin increased</sub_title>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="838"/>
                <counts group_id="E2" events="5" subjects_affected="5" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Pain in extremity</sub_title>
                <counts group_id="E1" events="13" subjects_affected="13" subjects_at_risk="838"/>
                <counts group_id="E2" events="21" subjects_affected="21" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Back Pain</sub_title>
                <counts group_id="E1" events="21" subjects_affected="19" subjects_at_risk="838"/>
                <counts group_id="E2" events="16" subjects_affected="16" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Arthralgia</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="838"/>
                <counts group_id="E2" events="14" subjects_affected="14" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Myalgia</sub_title>
                <counts group_id="E1" events="11" subjects_affected="10" subjects_at_risk="838"/>
                <counts group_id="E2" events="10" subjects_affected="10" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Dizziness</sub_title>
                <counts group_id="E1" events="28" subjects_affected="27" subjects_at_risk="838"/>
                <counts group_id="E2" events="31" subjects_affected="30" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="22" subjects_affected="21" subjects_at_risk="838"/>
                <counts group_id="E2" events="19" subjects_affected="17" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Syncope</sub_title>
                <counts group_id="E1" events="11" subjects_affected="11" subjects_at_risk="838"/>
                <counts group_id="E2" events="15" subjects_affected="13" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Haematuria</sub_title>
                <counts group_id="E1" events="15" subjects_affected="15" subjects_at_risk="838"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Dyspnoea</sub_title>
                <counts group_id="E1" events="45" subjects_affected="40" subjects_at_risk="838"/>
                <counts group_id="E2" events="49" subjects_affected="44" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Epistaxis</sub_title>
                <counts group_id="E1" events="17" subjects_affected="14" subjects_at_risk="838"/>
                <counts group_id="E2" events="22" subjects_affected="19" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Cough</sub_title>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="838"/>
                <counts group_id="E2" events="15" subjects_affected="14" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Dyspnoea exertional</sub_title>
                <counts group_id="E1" events="9" subjects_affected="8" subjects_at_risk="838"/>
                <counts group_id="E2" events="11" subjects_affected="11" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Hypertension</sub_title>
                <counts group_id="E1" events="33" subjects_affected="30" subjects_at_risk="838"/>
                <counts group_id="E2" events="25" subjects_affected="24" subjects_at_risk="846"/>
              </event>
              <event>
                <sub_title>Hypotension</sub_title>
                <counts group_id="E1" events="20" subjects_affected="20" subjects_at_risk="838"/>
                <counts group_id="E2" events="10" subjects_affected="9" subjects_at_risk="846"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The sponsor can review results communications to public release and can embargo communications regarding trial results for a period less or equal to 45 days from the time submitted to the sponsor. If the sponsor determines the communication would be detrimental to the intellectual property, the PI will redact or modify or will refrain the publication to a publisher or other party for an additional 120 days to permit the sponsor to file patent applications or take other steps to protect interests</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Patricia O'Mara, Clinical Trial Manager</name_or_title>
      <organization>Boston Scientific</organization>
      <phone>518-792-5673</phone>
      <email>patricia.o'mara@bsci.com</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01665053
org study id: S2067
secondary id: G120123
nct id: NCT01665053
lead sponsor: 
has dmc: Yes
The purpose of this study is to assess the safety and effectiveness of the SYNERGY
      Everolimus-Eluting Platinum Chromium Coronary Stent System for the treatment of subjects with
      atherosclerotic lesion(s) ≤ 34 mm in length (by visual estimate) in native coronary arteries
      ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate).
A concurrent, non-randomized, single-arm, pharmacokinetic (PK) substudy and a consecutive,
      non-randomized, single-arm, Diabetes substudy will also enroll under the EVOLVE II protocol.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Percentage of Participants With Target Lesion Failure (TLF) at 12 Months
time frame: 12 months
description: TLF is defined as any ischemia-driven revascularization of the target lesion, myocardial infarction (Q-wave and non-Q-wave) related to the target vessel, or cardiac death.
measure: Percentage of Participants With Target Lesion Revascularization (TLR) at 12 Months.
time frame: 12 months
description: The TLR overall rate includes: TLR Percutaneous Coronary Intervention (PCI) & TLR Coronary Artery Bypass Graft (CABG).
measure: Percentage of Participants With Target Vessel Revascularization (TVR) at 12 Months.
time frame: 12 months
description: TVR overall includes: TVR PCI & TVR CABG.
measure: Percentage of Participants With Target Vessel Failure (TVF) at 12 Month.
time frame: 12 months
description: Target Vessel Failure is defined as any ischemic-driven revascularization of the target vessel, MI related to the target vessel, or any cardiac death.
measure: Percentage of Participants With Myocardial Infarction at 12 Month.
time frame: 12 months
description: The MI rate includes: MI's related to the Target Vessel, MI's with unknown relationship to the Target Vessel and MI's not related to the Target Vessel.
measure: Percentage of Participants With Cardiac Death at 12 Month.
time frame: 12 months
measure: Percentage of Participants With Non-Cardiac Death at 12 Month.
time frame: 12 months
measure: Percentage of Patients That Died at 12 Months.
time frame: 12 months
description: The Death rate includes Cardiac- & Non-Cardiac Death.
measure: Percentage of Patients With Cardiac Death or Myocardial Infarction (MI) at 12 Month.
time frame: 12 months
measure: Percentage of Participants Who Died or Had an Myocardial Infarction (MI) at 12 Month.
time frame: 12 months
measure: Percentage of Participants Who Died, Had an Myocardial Infarction (MI) or a Target Vessel Revascularization (TVR) at12 Month.
time frame: 12 months
measure: Percentage of Participants With a ARC (Academic Research Consortium) Stent Thrombosis Rate at 12 Month.
time frame: 12 months
measure: Percentage of Patients With a Stroke at 12 Month.
time frame: 12 months
description: The stroke rate includes: Ischemic- , Hemorraghic- & Undetermined Stroke.
measure: Periprocedural Technical Success Rate.
time frame: Day 1 (periprocedure)
description: Technical Success Rate is defined as successful delivery and deployment of the study stent to the target vessel, without balloon rupture or stent embolization, and post-procedure diameter stenosis less then 30% in 2 near-orthogonal projections with TIMI 3 flow in the target lesion. Technical success is lesion based.
measure: Periprocedural Clinical Procedural Success Rate
time frame: Day 1 (periprocedure)
description: Procedural Success Rate is defined as post-procedure diameter less then 30% in 2 near-orthogonal projections with TIMI 3 flow in all target lesions without occurrence of in-hospital cardiac death, MI, TVR. Procedural success rate is subject based.
measure: Percentage of Participants With a Target Lesion Failure (TLF) at 12 Month.
time frame: 12 month
measure: Percentage of Patients With Revascularization (=All Revascularizations) at 12 Month.
time frame: 12 Month
description: All CEC adjudicated revascularization at 12 month (Intent to treat population).
arm group label: Promus Element Plus
arm group type: Active Comparator
description: PROMUS Element Plus is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a polymer coating).
arm group label: SYNERGY
arm group type: Experimental
description: SYNERGY is a device/drug combination product composed of two components, a device (coronary stent system including a platinum chromium stent platform) and a drug product (a formulation of everolimus contained in a bioabsorbable polymer coating).
intervention type: Device
intervention name: PROMUS Element Plus
description: A drug eluting coronary stent system
arm group label: Promus Element Plus
intervention type: Device
intervention name: SYNERGY
description: A drug eluting coronary stent system
arm group label: SYNERGY
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Peter M Maurer, MPH
role: Study Director
affiliation: Boston Scientific Corporation
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country: Australia
country: Austria
country: Belgium
country: Canada
country: Denmark
country: Finland
country: France
country: Italy
country: Japan
country: Latvia
country: Netherlands
country: New Zealand
country: Poland
country: Singapore
country: Spain
country: United States
responsible party type: Sponsor
mesh term: Coronary Artery Disease
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