<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/NCT01703000</url>
  </required_header>
  <id_info>
    <org_study_id>NG PROMUS Clinical Trial S2294</org_study_id>
    <nct_id>NCT01703000</nct_id>
  </id_info>
  <brief_title>NG PROMUS Stent System for the Treatment of Atherosclerotic Coronary Lesions</brief_title>
  <official_title>NG PROMUS: A Prospective, Multicenter Trial to Assess the NG PROMUS Everolimus-Eluting Platinum Chromium Coronary Stent System (NG PROMUS 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>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      NG PROMUS: A Prospective, Multicenter Trial to Assess the NG PROMUS Everolimus-Eluting&#xD;
      Platinum Chromium Coronary Stent System (NG PROMUS Stent System) for the Treatment of&#xD;
      Atherosclerotic Lesion(s)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate clinical and peri-procedural angiographic and intravascular ultrasound (IVUS)&#xD;
      outcomes for the NG PROMUS Everolimus-Eluting Platinum Chromium Coronary Stent System (NG&#xD;
      PROMUS Stent System) in the treatment of subjects with atherosclerotic lesion(s) ≤ 34 mm in&#xD;
      length (by visual estimate) in native coronary arteries ≥ 2.50 mm to ≤ 4.0 mm in diameter (by&#xD;
      visual estimate)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2012</start_date>
  <completion_date type="Actual">March 2013</completion_date>
  <primary_completion_date type="Actual">March 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Technical Success Rate</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day</time_frame>
    <description>Technical success is defined as successful delivery and deployment of the study stent to the target lesion, without balloon rupture or stent embolization, and post-procedure diameter stenosis of &lt;30% assessed in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Target Lesion Revascularization (TLR) Rate</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days</time_frame>
    <description>Target lesion revascularization is any ischemia-driven repeat percutaneous intervention, to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. A TLR will be considered as ischemia-driven if the target lesion diameter stenosis is &gt;/= 50% by QCA and there is presence of clinical or functional ischemia which cannot be explained by other coronary or graft lesions. Clinical or functional ischemia is any of the following:&#xD;
The subject has a positive functional study corresponding to the area served by the target lesion.&#xD;
The subject has ischemic ECG changes at rest in a distribution consistent with the target vessel.&#xD;
The subject has ischemic symptoms referable to the target lesion. A TLR will be considered as ischemia-driven if the lesion diameter stenosis is &gt;/= 70% by QCA even in the absence of clinical or functional ischemia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target Lesion Failure (TLF) Rate</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days</time_frame>
    <description>Target lesion failure is any ischemia-driven revascularization of the target lesion, MI (Q-wave and non-Q-wave) related to the target vessel, or (cardiac) death. For the purposes of this protocol, if it cannot be determined with certainty whether the MI was related to the target vessel, it will be considered a TLF.&#xD;
The MI definition used for Target Lesion Failure was the PLATINUM MI definition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target Vessel Revascularization (TVR) Rate</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days</time_frame>
    <description>Target vessel revascularization is defined as a TLR or a TVR remote. Target vessel revascularization remote is any ischemia-driven repeat percutaneous intervention, to improve blood flow, or bypass surgery of not previously existing lesions diameter stenosis &gt;/= 50% by QCA in the target vessel, excluding the target lesion. A TVR will be considered ischemia-driven if the target vessel diameter stenosis is &gt;/= 50% by QCA and any of the following are present:&#xD;
The subject has a positive functional study corresponding to the area served by the target vessel.&#xD;
The subject has ischemic ECG changes at rest in a distribution consistent with the target vessel.&#xD;
The subject has ischemic symptoms referable to the target vessel. A TVR will also be considered as ischemia-driven if the lesion diameter stenosis is &gt;/=70% even in the absence of clinical or functional ischemia.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target Vessel Failure (TVF) Rate</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days</time_frame>
    <description>Target vessel failure is any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.&#xD;
The MI definition used was the PLATINUM MI definition.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days</time_frame>
    <description>MI will be defined according to the PLATINUM Definition of MI with evidence pre-specified for i) Spontaneous, ii) PCI-related, iii) CABG related, and iv) autopsy evidence criteria.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac Death Rate</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days</time_frame>
    <description>Cardiac death is defined as death due to any of the following.&#xD;
Acute MI&#xD;
Cardiac perforation/pericardial tamponade&#xD;
Arrhythmia or conduction abnormality&#xD;
CVA through hospital discharge or CVA suspected of being related to the procedure&#xD;
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery&#xD;
Any death in which a cardiac cause cannot be excluded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-cardiac Death Rate</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days</time_frame>
    <description>Non-cardiac death is defined as a death not due to any of the following:&#xD;
Acute MI&#xD;
Cardiac perforation/pericardial tamponade&#xD;
Arrhythmia or conduction abnormality&#xD;
CVA through hospital discharge or CVA suspected of being related to the procedure&#xD;
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery&#xD;
Any death in which a cardiac cause cannot be excluded</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All Death Rate</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days</time_frame>
    <description>Death is categorized as cardiac or non-cardiac deaths.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac Death or MI Rate</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days</time_frame>
    <description>Any cardiac death or MI event meeting the criteria defined for a cardiac death or MI.&#xD;
MI definition used was the PLATINUM definition for MI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All Death or MI Rate</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days</time_frame>
    <description>Any all-cause mortality event or MI meeting the criteria defined for any death or MI.&#xD;
MI definition used was the PLATINUM definition for MI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All Death/MI/TVR Rate</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days</time_frame>
    <description>Any event meeting the pre-specified criteria for any death, MI, or TVR.&#xD;
MI definition used was the PLATINUM definition for MI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent Thrombosis Rate (by Academic Research Consortium [ARC] Definitions)</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days</time_frame>
    <description>Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guide catheter has been removed and the patient left the catheterization lab.&#xD;
Timing:&#xD;
Acute stent thrombosis*: 0 24 hours after stent implantation&#xD;
Subacute stent thrombosis*: &gt;24 hours to 30 days after stent implantation&#xD;
Late stent thrombosis: &gt;30 days to 1 year after stent implantation&#xD;
Very late stent thrombosis: &gt;1 year after stent implantation * Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis is 0 30 days.&#xD;
Stent thrombosis may be defined as:&#xD;
Confirmed/definite&#xD;
Probable&#xD;
Possible&#xD;
Confirmed/Definite (is considered either angiographic confirmed or pathologic confirmed)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical Procedural Success Rate</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day</time_frame>
    <description>Clinical procedural success is post-procedure diameter stenosis &lt;30% in 2 near-orthogonal projections with TIMI 3 flow in all target lesions, as visually assessed by the physician, without the occurrence of in-hospital MI, TVR, or cardiac death.&#xD;
MI definition used was the PLATINUM definition for MI.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-stent Percent Diameter Stenosis (%DS)</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day</time_frame>
    <description>As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA), the % diameter stenosis of the in-stent region.&#xD;
Percent diameter stenosis: Relative changes that occur in the percent diameter stenosis are provided by the following relationship: % diameter stenosis= (1-[Minimum Lumen Diameter/Reference diameter]) x 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-segment Percent Diameter Stenosis (%DS)</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day</time_frame>
    <description>As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA), the % diameter stenosis of the in-segment region (in-segment includes the stented region and 5 mm edge regions).&#xD;
Percent diameter stenosis: Relative changes that occur in the percent diameter stenosis are provided by the following relationship: % diameter stenosis= (1-[Minimum Lumen Diameter/Reference diameter]) x 100.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-stent Minimum Lumen Diameter (MLD)</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day</time_frame>
    <description>As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA); the minimum lumen diameter (MLD) measured at the in-stent region.&#xD;
The MLD is the mean minimum lumen diameter (mm) from 2 orthogonal views.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-segment Minimum Lumen Diameter (MLD)</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day</time_frame>
    <description>As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA); the minimum lumen diameter (MLD) measured at the in-segment region (in-segment includes the stented region and 5 mm edge regions).&#xD;
The MLD is the mean minimum lumen diameter (mm) from 2 orthogonal views.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute Gain</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day</time_frame>
    <description>Acute gain, as measured by angiographic core lab</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vessel Area</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day</time_frame>
    <description>As measured by IVUS, the mean vessel area (mm2).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent Area</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day</time_frame>
    <description>As measured by IVUS, the area of the stent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lumen Area</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day</time_frame>
    <description>As measured by IVUS, the area of the lumen.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vessel Volume</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day</time_frame>
    <description>As measured by IVUS, the volume of the vessel.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent Volume</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day</time_frame>
    <description>As measured by IVUS, the volume of the stent.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Lumen Volume</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day</time_frame>
    <description>As measured by IVUS, the volume of the lumen.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incomplete Apposition</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day</time_frame>
    <description>Incomplete apposition rate, as measured by the IVUS core lab.&#xD;
Binary assessment of presence of one or more stent struts separated from the vessel wall as detected through intravascular ultrasound (IVUS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percent Net Volume Obstruction</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day</time_frame>
    <description>The percentage of volume obstruction, as measured by the IVUS core lab.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Longitudinal Stent Deformation</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day</time_frame>
    <description>Longitudinal stent deformation, evidenced by longitudinal compression or elongation, as the result of crossing a newly deployed stent with a second device, (such as a balloon catheter, stent system or IVUS catheter), causing the second device to become caught on the stent when the second device is advanced or retracted.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">100</enrollment>
  <condition>Atherosclerosis</condition>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>NG PROMUS stent</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single-arm treatment group receiving interventional NG PROMUS study stent</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Percutaneous coronary intervention (NG PROMUS)</intervention_name>
    <description>Interventional coronary artery stenting with NG PROMUS study stent.</description>
    <arm_group_label>NG PROMUS stent</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Clinical Inclusion Criteria:&#xD;
&#xD;
          1. Subject must be at least 18 years of age&#xD;
&#xD;
          2. 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;
          3. Subject is eligible for percutaneous coronary intervention (PCI)&#xD;
&#xD;
          4. Subject has symptomatic coronary artery disease with objective evidence of ischemia or&#xD;
             silent ischemia&#xD;
&#xD;
          5. Subject is an acceptable candidate for coronary artery bypass grafting (CABG)&#xD;
&#xD;
          6. Subject is willing to comply with all protocol-required follow-up evaluation&#xD;
&#xD;
        Angiographic Inclusion Criteria:&#xD;
&#xD;
          1. Target lesion(s) must be located in a native coronary artery with a visually estimated&#xD;
             reference vessel diameter (RVD) ≥2.50 mm and ≤4.0 mm&#xD;
&#xD;
          2. Target lesion(s) length must be ≤34 mm (by visual estimate)&#xD;
&#xD;
          3. 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 test or&#xD;
             imaging stress test, or elevated biomarkers) prior to procedure&#xD;
&#xD;
          4. Coronary anatomy is likely to allow delivery of a study device to the target&#xD;
             lesions(s)&#xD;
&#xD;
          5. The first lesion treated must be successfully pre-dilated/pretreated Note: Successful&#xD;
             pre-dilatation/pretreatment refers to dilatation with a balloon catheter of&#xD;
             appropriate length and diameter, or pretreatment with directional or rotational&#xD;
             coronary atherectomy, laser or cutting/scoring balloon with no greater than 50%&#xD;
             residual stenosis and no dissection greater than National Heart, Lung, Blood Institute&#xD;
             (NHLBI) type C.&#xD;
&#xD;
        Clinical Exclusion Criteria:&#xD;
&#xD;
          1. Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with&#xD;
             acute ST elevation MI (STEMI)&#xD;
&#xD;
          2. Subject has cardiogenic shock, hemodynamic instability requiring inotropic or&#xD;
             mechanical circulatory support, intractable ventricular arrhythmias, or ongoing&#xD;
             intractable angina&#xD;
&#xD;
          3. Subject has received an organ transplant or is on a waiting list for an organ&#xD;
             transplant&#xD;
&#xD;
          4. Subject is receiving or scheduled to receive chemotherapy within 30 days before or&#xD;
             after the index procedure&#xD;
&#xD;
          5. Planned PCI (including staged procedures) or CABG after the index procedure&#xD;
&#xD;
          6. Subject previously treated at any time with intravascular brachytherapy&#xD;
&#xD;
          7. 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;
          8. Subject has one of the following (as assessed prior to the index procedure):Other&#xD;
             serious medical illness (e.g., cancer, congestive heart failure) with estimated life&#xD;
             expectancy of less than 24 months; Current problems with substance abuse (e.g.,&#xD;
             alcohol, cocaine, heroin, etc.);Planned procedure that may cause non-compliance with&#xD;
             the protocol or confound data interpretation&#xD;
&#xD;
          9. Subject is receiving chronic (≥72 hours) anticoagulation therapy (i.e., heparin,&#xD;
             coumadin) for indications other than acute coronary syndrome&#xD;
&#xD;
         10. Subject has a platelet count &lt;100,000 cells/mm3 or &gt;700,000 cells/mm3&#xD;
&#xD;
         11. Subject has a white blood cell (WBC) count &lt; 3,000 cells/mm3&#xD;
&#xD;
         12. Subject has documented or suspected liver disease, including laboratory evidence of&#xD;
             hepatitis&#xD;
&#xD;
         13. Subject is on dialysis or has baseline serum creatinine level &gt;2.0 mg/dL (177µmol/L)&#xD;
&#xD;
         14. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood&#xD;
             transfusions&#xD;
&#xD;
         15. Subject has had a history of cerebrovascular accident (CVA) or transient ischemic&#xD;
             attack (TIA) within the past 6 months&#xD;
&#xD;
         16. Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding&#xD;
&#xD;
         17. Subject has signs or symptoms of active heart failure (i.e., NYHA class IV) at the&#xD;
             time of the index procedure&#xD;
&#xD;
         18. Subject is participating in another investigational drug or device clinical trial that&#xD;
             has not reached its primary endpoint&#xD;
&#xD;
         19. Subject intends to participate in another investigational drug or device clinical&#xD;
             trial within 12 months after the index procedure&#xD;
&#xD;
         20. 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;
         21. 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:&#xD;
&#xD;
          1. Planned treatment of more than 3 lesions.&#xD;
&#xD;
          2. Planned treatment of lesions in more than 2 major epicardial vessels&#xD;
&#xD;
          3. Planned treatment of a single lesion with more than 1 stent&#xD;
&#xD;
          4. Subject has 2 target lesions in the same vessel that are separated by less than 15 mm&#xD;
             (by visual estimate)&#xD;
&#xD;
          5. Target lesion(s) is located in the left main&#xD;
&#xD;
          6. 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;
          7. Target lesion(s) is located within a saphenous vein graft or an arterial graft&#xD;
&#xD;
          8. Target lesion(s) will be accessed via a saphenous vein graft or arterial graft&#xD;
&#xD;
          9. Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide&#xD;
             wire crossing&#xD;
&#xD;
         10. 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;
         11. Target lesion(s) is restenotic from a previous stent implantation or study stent would&#xD;
             overlap with a previous stent&#xD;
&#xD;
         12. Subject has unprotected left main coronary artery disease (&gt;50% diameter stenosis)&#xD;
&#xD;
         13. 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;
         14. 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>John A Ormiston, MBChB, FRACP, FRACR</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mercy Angiography Unit, Ltd. Mercy Hospital</affiliation>
  </overall_official>
  <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>Mercy Angiography Unit, Ltd. Mercy Hospital</name>
      <address>
        <city>Auckland</city>
        <zip>1003</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Auckland City Hospital</name>
      <address>
        <city>Auckland</city>
        <zip>1010</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Shore Hospital</name>
      <address>
        <city>Auckland</city>
        <zip>1030</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Ascot Angiography</name>
      <address>
        <city>Auckland</city>
        <zip>1546</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christchurch</name>
      <address>
        <city>Christchurch</city>
        <zip>8140</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Middlemore Hospital</name>
      <address>
        <city>Otahuhu</city>
        <zip>1640</zip>
        <country>New Zealand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National University Hospital Singapore</name>
      <address>
        <city>Singapore</city>
        <zip>119228</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Heart Center Singapore</name>
      <address>
        <city>Singapore</city>
        <zip>168752</zip>
        <country>Singapore</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>New Zealand</country>
    <country>Singapore</country>
  </location_countries>
  <link>
    <url>http://www.pharma.us.novartis.com/info/products/name/zortress.jsp</url>
    <description>Drug-eluting product information from Manufacturer</description>
  </link>
  <verification_date>March 2014</verification_date>
  <study_first_submitted>October 5, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 10, 2012</study_first_posted>
  <results_first_submitted>December 16, 2013</results_first_submitted>
  <results_first_submitted_qc>February 20, 2014</results_first_submitted_qc>
  <results_first_posted type="Estimate">March 21, 2014</results_first_posted>
  <last_update_submitted>March 20, 2014</last_update_submitted>
  <last_update_submitted_qc>March 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>drug eluting coronary stent</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Atherosclerosis</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Recruitment of subjects for NG PROMUS study started on November 20, 2012 and completed on March 12, 2013. Subjects were recruited at 9 investigational centers in Australia, New Zealand and Singapore.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>NG PROMUS Stent</title>
          <description>Single-arm treatment group receiving interventional NG PROMUS study stent&#xD;
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="100"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="99"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Death</title>
              <participants_list>
                <participants group_id="P1" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Single arm with investigational NG PROMUS Everolimus Eluting Coronary Stent System&#xD;
N=100 patients, N=119 Lesions, N=127 Stents</population>
      <group_list>
        <group group_id="B1">
          <title>NG PROMUS Stent</title>
          <description>Single-arm treatment group receiving interventional NG PROMUS study stent&#xD;
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="100"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.72" spread="9.73"/>
                  </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="15"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="85"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black, of African Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </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="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not disclosed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </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="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Australia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>New Zealand</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="88"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cardiac History</title>
          <description>Note: A single participant could potentially experience multiple categories listed below.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Previous Percutaneous Coronary Intervention</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Previous Coronary Artery Bypass Graft</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Previous Myocardial Infarction</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Congestive Heart Failure</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Stable Angina</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unstable Angina</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Silent Ischemia</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Cardiac Risk Factors</title>
          <description>Note: A single participant could potentially experience multiple categories listed below.</description>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Smoking, Ever</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Medically Treated Diabetes</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hyperlipidemia Requiring Medication</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="78"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hypertension Requiring Medication</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Family History of Coronary Artery Disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Lesion Characteristics: Target Lesion Vessel</title>
          <description>Note: A single participant could potentially experience multiple categories listed below.</description>
          <units>Lesions</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Left Anterior Descending Artery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="60"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Circumflex Artery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Right Coronary Artery</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Lesion Characteristic: Lesion Location</title>
          <description>Note: A single participant could potentially experience multiple categories listed below.</description>
          <units>Lesions</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Ostial</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Proximal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Mid</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Distal</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Lesion Characteristic: Lesion Length</title>
          <description>Note: A single participant could potentially experience multiple categories listed below.</description>
          <units>Lesions</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Less than or equal to 20 mm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="91"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Greater than 20 mm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Lesion Characteristics</title>
          <description>Note: A single participant could potentially experience multiple categories listed below.</description>
          <units>Lesions</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Tortuosity, Any</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Calcification, Any</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="35"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ulcerated</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aneurysm</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Bifurcation</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Total Occlusion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Eccentric Lesion</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="86"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Lesion Characteristic: Pre-Procedure Thrombolysis in Myocardial Infarction (TIMI) Flow</title>
          <description>Note: A single participant could potentially experience multiple categories listed below.</description>
          <units>Lesions</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>0 (no perfusion)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>1 (penetration with minimal perfusion)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2 (partial perfusion)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3 (complete perfusion)</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="108"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Lesion Characteristics by Quantitative Cornary Angiography</title>
          <units>Millimeters</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <title>Reference Vessel Diameter</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.78" spread="0.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Minimum Lumen Diameter</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0.85" spread="0.29"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Lesion Length</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="16.05" spread="7.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Lesion Characteristic: Percent Diameter Stenosis by QCA</title>
          <units>Percent Diameter Stenosis</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="69.12" spread="9.69"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Technical Success Rate</title>
        <description>Technical success is defined as successful delivery and deployment of the study stent to the target lesion, without balloon rupture or stent embolization, and post-procedure diameter stenosis of &lt;30% assessed in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician</description>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NG PROMUS Stent</title>
            <description>Single-arm treatment group receiving interventional NG PROMUS study stent&#xD;
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.</description>
          </group>
        </group_list>
        <measure>
          <title>Technical Success Rate</title>
          <description>Technical success is defined as successful delivery and deployment of the study stent to the target lesion, without balloon rupture or stent embolization, and post-procedure diameter stenosis of &lt;30% assessed in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician</description>
          <units>percentage of lesions</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Lesions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="119"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99.2" lower_limit="95.4" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Target Lesion Revascularization (TLR) Rate</title>
        <description>Target lesion revascularization is any ischemia-driven repeat percutaneous intervention, to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. A TLR will be considered as ischemia-driven if the target lesion diameter stenosis is &gt;/= 50% by QCA and there is presence of clinical or functional ischemia which cannot be explained by other coronary or graft lesions. Clinical or functional ischemia is any of the following:&#xD;
The subject has a positive functional study corresponding to the area served by the target lesion.&#xD;
The subject has ischemic ECG changes at rest in a distribution consistent with the target vessel.&#xD;
The subject has ischemic symptoms referable to the target lesion. A TLR will be considered as ischemia-driven if the lesion diameter stenosis is &gt;/= 70% by QCA even in the absence of clinical or functional ischemia.</description>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NG PROMUS Stent</title>
            <description>Single-arm treatment group receiving interventional NG PROMUS study stent&#xD;
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.</description>
          </group>
        </group_list>
        <measure>
          <title>Target Lesion Revascularization (TLR) Rate</title>
          <description>Target lesion revascularization is any ischemia-driven repeat percutaneous intervention, to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. A TLR will be considered as ischemia-driven if the target lesion diameter stenosis is &gt;/= 50% by QCA and there is presence of clinical or functional ischemia which cannot be explained by other coronary or graft lesions. Clinical or functional ischemia is any of the following:&#xD;
The subject has a positive functional study corresponding to the area served by the target lesion.&#xD;
The subject has ischemic ECG changes at rest in a distribution consistent with the target vessel.&#xD;
The subject has ischemic symptoms referable to the target lesion. A TLR will be considered as ischemia-driven if the lesion diameter stenosis is &gt;/= 70% by QCA even in the absence of clinical or functional ischemia.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Target Lesion Failure (TLF) Rate</title>
        <description>Target lesion failure is any ischemia-driven revascularization of the target lesion, MI (Q-wave and non-Q-wave) related to the target vessel, or (cardiac) death. For the purposes of this protocol, if it cannot be determined with certainty whether the MI was related to the target vessel, it will be considered a TLF.&#xD;
The MI definition used for Target Lesion Failure was the PLATINUM MI definition.</description>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NG PROMUS Stent</title>
            <description>Single-arm treatment group receiving interventional NG PROMUS study stent&#xD;
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.</description>
          </group>
        </group_list>
        <measure>
          <title>Target Lesion Failure (TLF) Rate</title>
          <description>Target lesion failure is any ischemia-driven revascularization of the target lesion, MI (Q-wave and non-Q-wave) related to the target vessel, or (cardiac) death. For the purposes of this protocol, if it cannot be determined with certainty whether the MI was related to the target vessel, it will be considered a TLF.&#xD;
The MI definition used for Target Lesion Failure was the PLATINUM MI definition.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Target Vessel Revascularization (TVR) Rate</title>
        <description>Target vessel revascularization is defined as a TLR or a TVR remote. Target vessel revascularization remote is any ischemia-driven repeat percutaneous intervention, to improve blood flow, or bypass surgery of not previously existing lesions diameter stenosis &gt;/= 50% by QCA in the target vessel, excluding the target lesion. A TVR will be considered ischemia-driven if the target vessel diameter stenosis is &gt;/= 50% by QCA and any of the following are present:&#xD;
The subject has a positive functional study corresponding to the area served by the target vessel.&#xD;
The subject has ischemic ECG changes at rest in a distribution consistent with the target vessel.&#xD;
The subject has ischemic symptoms referable to the target vessel. A TVR will also be considered as ischemia-driven if the lesion diameter stenosis is &gt;/=70% even in the absence of clinical or functional ischemia.</description>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NG PROMUS Stent</title>
            <description>Single-arm treatment group receiving interventional NG PROMUS study stent&#xD;
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.</description>
          </group>
        </group_list>
        <measure>
          <title>Target Vessel Revascularization (TVR) Rate</title>
          <description>Target vessel revascularization is defined as a TLR or a TVR remote. Target vessel revascularization remote is any ischemia-driven repeat percutaneous intervention, to improve blood flow, or bypass surgery of not previously existing lesions diameter stenosis &gt;/= 50% by QCA in the target vessel, excluding the target lesion. A TVR will be considered ischemia-driven if the target vessel diameter stenosis is &gt;/= 50% by QCA and any of the following are present:&#xD;
The subject has a positive functional study corresponding to the area served by the target vessel.&#xD;
The subject has ischemic ECG changes at rest in a distribution consistent with the target vessel.&#xD;
The subject has ischemic symptoms referable to the target vessel. A TVR will also be considered as ischemia-driven if the lesion diameter stenosis is &gt;/=70% even in the absence of clinical or functional ischemia.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Target Vessel Failure (TVF) Rate</title>
        <description>Target vessel failure is any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.&#xD;
The MI definition used was the PLATINUM MI definition.</description>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NG PROMUS Stent</title>
            <description>Single-arm treatment group receiving interventional NG PROMUS study stent&#xD;
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.</description>
          </group>
        </group_list>
        <measure>
          <title>Target Vessel Failure (TVF) Rate</title>
          <description>Target vessel failure is any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.&#xD;
The MI definition used was the PLATINUM MI definition.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate</title>
        <description>MI will be defined according to the PLATINUM Definition of MI with evidence pre-specified for i) Spontaneous, ii) PCI-related, iii) CABG related, and iv) autopsy evidence criteria.</description>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NG PROMUS Stent</title>
            <description>Single-arm treatment group receiving interventional NG PROMUS study stent&#xD;
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.</description>
          </group>
        </group_list>
        <measure>
          <title>Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate</title>
          <description>MI will be defined according to the PLATINUM Definition of MI with evidence pre-specified for i) Spontaneous, ii) PCI-related, iii) CABG related, and iv) autopsy evidence criteria.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cardiac Death Rate</title>
        <description>Cardiac death is defined as death due to any of the following.&#xD;
Acute MI&#xD;
Cardiac perforation/pericardial tamponade&#xD;
Arrhythmia or conduction abnormality&#xD;
CVA through hospital discharge or CVA suspected of being related to the procedure&#xD;
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery&#xD;
Any death in which a cardiac cause cannot be excluded</description>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NG PROMUS Stent</title>
            <description>Single-arm treatment group receiving interventional NG PROMUS study stent&#xD;
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.</description>
          </group>
        </group_list>
        <measure>
          <title>Cardiac Death Rate</title>
          <description>Cardiac death is defined as death due to any of the following.&#xD;
Acute MI&#xD;
Cardiac perforation/pericardial tamponade&#xD;
Arrhythmia or conduction abnormality&#xD;
CVA through hospital discharge or CVA suspected of being related to the procedure&#xD;
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery&#xD;
Any death in which a cardiac cause cannot be excluded</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Non-cardiac Death Rate</title>
        <description>Non-cardiac death is defined as a death not due to any of the following:&#xD;
Acute MI&#xD;
Cardiac perforation/pericardial tamponade&#xD;
Arrhythmia or conduction abnormality&#xD;
CVA through hospital discharge or CVA suspected of being related to the procedure&#xD;
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery&#xD;
Any death in which a cardiac cause cannot be excluded</description>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NG PROMUS Stent</title>
            <description>Single-arm treatment group receiving interventional NG PROMUS study stent&#xD;
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.</description>
          </group>
        </group_list>
        <measure>
          <title>Non-cardiac Death Rate</title>
          <description>Non-cardiac death is defined as a death not due to any of the following:&#xD;
Acute MI&#xD;
Cardiac perforation/pericardial tamponade&#xD;
Arrhythmia or conduction abnormality&#xD;
CVA through hospital discharge or CVA suspected of being related to the procedure&#xD;
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery&#xD;
Any death in which a cardiac cause cannot be excluded</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>All Death Rate</title>
        <description>Death is categorized as cardiac or non-cardiac deaths.</description>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NG PROMUS Stent</title>
            <description>Single-arm treatment group receiving interventional NG PROMUS study stent&#xD;
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.</description>
          </group>
        </group_list>
        <measure>
          <title>All Death Rate</title>
          <description>Death is categorized as cardiac or non-cardiac deaths.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cardiac Death or MI Rate</title>
        <description>Any cardiac death or MI event meeting the criteria defined for a cardiac death or MI.&#xD;
MI definition used was the PLATINUM definition for MI.</description>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NG PROMUS Stent</title>
            <description>Single-arm treatment group receiving interventional NG PROMUS study stent&#xD;
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.</description>
          </group>
        </group_list>
        <measure>
          <title>Cardiac Death or MI Rate</title>
          <description>Any cardiac death or MI event meeting the criteria defined for a cardiac death or MI.&#xD;
MI definition used was the PLATINUM definition for MI.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>All Death or MI Rate</title>
        <description>Any all-cause mortality event or MI meeting the criteria defined for any death or MI.&#xD;
MI definition used was the PLATINUM definition for MI.</description>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NG PROMUS Stent</title>
            <description>Single-arm treatment group receiving interventional NG PROMUS study stent&#xD;
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.</description>
          </group>
        </group_list>
        <measure>
          <title>All Death or MI Rate</title>
          <description>Any all-cause mortality event or MI meeting the criteria defined for any death or MI.&#xD;
MI definition used was the PLATINUM definition for MI.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>All Death/MI/TVR Rate</title>
        <description>Any event meeting the pre-specified criteria for any death, MI, or TVR.&#xD;
MI definition used was the PLATINUM definition for MI.</description>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NG PROMUS Stent</title>
            <description>Single-arm treatment group receiving interventional NG PROMUS study stent&#xD;
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.</description>
          </group>
        </group_list>
        <measure>
          <title>All Death/MI/TVR Rate</title>
          <description>Any event meeting the pre-specified criteria for any death, MI, or TVR.&#xD;
MI definition used was the PLATINUM definition for MI.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stent Thrombosis Rate (by Academic Research Consortium [ARC] Definitions)</title>
        <description>Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guide catheter has been removed and the patient left the catheterization lab.&#xD;
Timing:&#xD;
Acute stent thrombosis*: 0 24 hours after stent implantation&#xD;
Subacute stent thrombosis*: &gt;24 hours to 30 days after stent implantation&#xD;
Late stent thrombosis: &gt;30 days to 1 year after stent implantation&#xD;
Very late stent thrombosis: &gt;1 year after stent implantation * Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis is 0 30 days.&#xD;
Stent thrombosis may be defined as:&#xD;
Confirmed/definite&#xD;
Probable&#xD;
Possible&#xD;
Confirmed/Definite (is considered either angiographic confirmed or pathologic confirmed)</description>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NG PROMUS Stent</title>
            <description>Single-arm treatment group receiving interventional NG PROMUS study stent&#xD;
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.</description>
          </group>
        </group_list>
        <measure>
          <title>Stent Thrombosis Rate (by Academic Research Consortium [ARC] Definitions)</title>
          <description>Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guide catheter has been removed and the patient left the catheterization lab.&#xD;
Timing:&#xD;
Acute stent thrombosis*: 0 24 hours after stent implantation&#xD;
Subacute stent thrombosis*: &gt;24 hours to 30 days after stent implantation&#xD;
Late stent thrombosis: &gt;30 days to 1 year after stent implantation&#xD;
Very late stent thrombosis: &gt;1 year after stent implantation * Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis is 0 30 days.&#xD;
Stent thrombosis may be defined as:&#xD;
Confirmed/definite&#xD;
Probable&#xD;
Possible&#xD;
Confirmed/Definite (is considered either angiographic confirmed or pathologic confirmed)</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Procedural Success Rate</title>
        <description>Clinical procedural success is post-procedure diameter stenosis &lt;30% in 2 near-orthogonal projections with TIMI 3 flow in all target lesions, as visually assessed by the physician, without the occurrence of in-hospital MI, TVR, or cardiac death.&#xD;
MI definition used was the PLATINUM definition for MI.</description>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NG PROMUS Stent</title>
            <description>Single-arm treatment group receiving interventional NG PROMUS study stent&#xD;
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.</description>
          </group>
        </group_list>
        <measure>
          <title>Clinical Procedural Success Rate</title>
          <description>Clinical procedural success is post-procedure diameter stenosis &lt;30% in 2 near-orthogonal projections with TIMI 3 flow in all target lesions, as visually assessed by the physician, without the occurrence of in-hospital MI, TVR, or cardiac death.&#xD;
MI definition used was the PLATINUM definition for MI.</description>
          <units>percentage of participants</units>
          <param>Number</param>
          <dispersion>95% Confidence Interval</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="99" lower_limit="94.6" upper_limit="100"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>In-stent Percent Diameter Stenosis (%DS)</title>
        <description>As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA), the % diameter stenosis of the in-stent region.&#xD;
Percent diameter stenosis: Relative changes that occur in the percent diameter stenosis are provided by the following relationship: % diameter stenosis= (1-[Minimum Lumen Diameter/Reference diameter]) x 100.</description>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NG PROMUS Stent</title>
            <description>Single-arm treatment group receiving interventional NG PROMUS study stent&#xD;
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.</description>
          </group>
        </group_list>
        <measure>
          <title>In-stent Percent Diameter Stenosis (%DS)</title>
          <description>As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA), the % diameter stenosis of the in-stent region.&#xD;
Percent diameter stenosis: Relative changes that occur in the percent diameter stenosis are provided by the following relationship: % diameter stenosis= (1-[Minimum Lumen Diameter/Reference diameter]) x 100.</description>
          <units>In-Stent % Diameter Stenosis</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Lesions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="119"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.86" spread="8.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>In-segment Percent Diameter Stenosis (%DS)</title>
        <description>As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA), the % diameter stenosis of the in-segment region (in-segment includes the stented region and 5 mm edge regions).&#xD;
Percent diameter stenosis: Relative changes that occur in the percent diameter stenosis are provided by the following relationship: % diameter stenosis= (1-[Minimum Lumen Diameter/Reference diameter]) x 100.</description>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NG PROMUS Stent</title>
            <description>Single-arm treatment group receiving interventional NG PROMUS study stent&#xD;
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.</description>
          </group>
        </group_list>
        <measure>
          <title>In-segment Percent Diameter Stenosis (%DS)</title>
          <description>As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA), the % diameter stenosis of the in-segment region (in-segment includes the stented region and 5 mm edge regions).&#xD;
Percent diameter stenosis: Relative changes that occur in the percent diameter stenosis are provided by the following relationship: % diameter stenosis= (1-[Minimum Lumen Diameter/Reference diameter]) x 100.</description>
          <units>Diameter Stenosis, In-Segment (%)</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Lesions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="119"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="18.14" spread="7.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>In-stent Minimum Lumen Diameter (MLD)</title>
        <description>As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA); the minimum lumen diameter (MLD) measured at the in-stent region.&#xD;
The MLD is the mean minimum lumen diameter (mm) from 2 orthogonal views.</description>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NG PROMUS Stent</title>
            <description>Single-arm treatment group receiving interventional NG PROMUS study stent&#xD;
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.</description>
          </group>
        </group_list>
        <measure>
          <title>In-stent Minimum Lumen Diameter (MLD)</title>
          <description>As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA); the minimum lumen diameter (MLD) measured at the in-stent region.&#xD;
The MLD is the mean minimum lumen diameter (mm) from 2 orthogonal views.</description>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Lesions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="119"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.69" spread="0.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>In-segment Minimum Lumen Diameter (MLD)</title>
        <description>As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA); the minimum lumen diameter (MLD) measured at the in-segment region (in-segment includes the stented region and 5 mm edge regions).&#xD;
The MLD is the mean minimum lumen diameter (mm) from 2 orthogonal views.</description>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NG PROMUS Stent</title>
            <description>Single-arm treatment group receiving interventional NG PROMUS study stent&#xD;
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.</description>
          </group>
        </group_list>
        <measure>
          <title>In-segment Minimum Lumen Diameter (MLD)</title>
          <description>As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA); the minimum lumen diameter (MLD) measured at the in-segment region (in-segment includes the stented region and 5 mm edge regions).&#xD;
The MLD is the mean minimum lumen diameter (mm) from 2 orthogonal views.</description>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Lesions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="119"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.31" spread="0.46"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Acute Gain</title>
        <description>Acute gain, as measured by angiographic core lab</description>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NG PROMUS Stent</title>
            <description>Single-arm treatment group receiving interventional NG PROMUS study stent&#xD;
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.</description>
          </group>
        </group_list>
        <measure>
          <title>Acute Gain</title>
          <description>Acute gain, as measured by angiographic core lab</description>
          <units>mm</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="1.84" spread="0.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Vessel Area</title>
        <description>As measured by IVUS, the mean vessel area (mm2).</description>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NG PROMUS Stent</title>
            <description>Single-arm treatment group receiving interventional NG PROMUS study stent&#xD;
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.</description>
          </group>
        </group_list>
        <measure>
          <title>Vessel Area</title>
          <description>As measured by IVUS, the mean vessel area (mm2).</description>
          <units>mm^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Lesions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.1" spread="4.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stent Area</title>
        <description>As measured by IVUS, the area of the stent.</description>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NG PROMUS Stent</title>
            <description>Single-arm treatment group receiving interventional NG PROMUS study stent&#xD;
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.</description>
          </group>
        </group_list>
        <measure>
          <title>Stent Area</title>
          <description>As measured by IVUS, the area of the stent.</description>
          <units>mm^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Lesions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.83" spread="2.38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lumen Area</title>
        <description>As measured by IVUS, the area of the lumen.</description>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NG PROMUS Stent</title>
            <description>Single-arm treatment group receiving interventional NG PROMUS study stent&#xD;
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.</description>
          </group>
        </group_list>
        <measure>
          <title>Lumen Area</title>
          <description>As measured by IVUS, the area of the lumen.</description>
          <units>mm^2</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Lesions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.76" spread="2.25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Vessel Volume</title>
        <description>As measured by IVUS, the volume of the vessel.</description>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NG PROMUS Stent</title>
            <description>Single-arm treatment group receiving interventional NG PROMUS study stent&#xD;
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.</description>
          </group>
        </group_list>
        <measure>
          <title>Vessel Volume</title>
          <description>As measured by IVUS, the volume of the vessel.</description>
          <units>mm^3</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Lesions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="99"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="354.34" spread="181.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stent Volume</title>
        <description>As measured by IVUS, the volume of the stent.</description>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NG PROMUS Stent</title>
            <description>Single-arm treatment group receiving interventional NG PROMUS study stent&#xD;
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.</description>
          </group>
        </group_list>
        <measure>
          <title>Stent Volume</title>
          <description>As measured by IVUS, the volume of the stent.</description>
          <units>mm^3</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Lesions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="185.3" spread="91.75"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Lumen Volume</title>
        <description>As measured by IVUS, the volume of the lumen.</description>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NG PROMUS Stent</title>
            <description>Single-arm treatment group receiving interventional NG PROMUS study stent&#xD;
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.</description>
          </group>
        </group_list>
        <measure>
          <title>Lumen Volume</title>
          <description>As measured by IVUS, the volume of the lumen.</description>
          <units>mm^3</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Lesions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="182.6" spread="87.93"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Incomplete Apposition</title>
        <description>Incomplete apposition rate, as measured by the IVUS core lab.&#xD;
Binary assessment of presence of one or more stent struts separated from the vessel wall as detected through intravascular ultrasound (IVUS).</description>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NG PROMUS Stent</title>
            <description>Single-arm treatment group receiving interventional NG PROMUS study stent&#xD;
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.</description>
          </group>
        </group_list>
        <measure>
          <title>Incomplete Apposition</title>
          <description>Incomplete apposition rate, as measured by the IVUS core lab.&#xD;
Binary assessment of presence of one or more stent struts separated from the vessel wall as detected through intravascular ultrasound (IVUS).</description>
          <units>percentage of lesions</units>
          <param>Number</param>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Lesions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="101"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Percent Net Volume Obstruction</title>
        <description>The percentage of volume obstruction, as measured by the IVUS core lab.</description>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NG PROMUS Stent</title>
            <description>Single-arm treatment group receiving interventional NG PROMUS study stent&#xD;
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.</description>
          </group>
        </group_list>
        <measure>
          <title>Percent Net Volume Obstruction</title>
          <description>The percentage of volume obstruction, as measured by the IVUS core lab.</description>
          <units>% of volume</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <units_analyzed>Participants</units_analyzed>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
            <analyzed>
              <units>Lesions</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0" spread=".01"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Longitudinal Stent Deformation</title>
        <description>Longitudinal stent deformation, evidenced by longitudinal compression or elongation, as the result of crossing a newly deployed stent with a second device, (such as a balloon catheter, stent system or IVUS catheter), causing the second device to become caught on the stent when the second device is advanced or retracted.</description>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day</time_frame>
        <group_list>
          <group group_id="O1">
            <title>NG PROMUS Stent</title>
            <description>Single-arm treatment group receiving interventional NG PROMUS study stent&#xD;
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.</description>
          </group>
        </group_list>
        <measure>
          <title>Longitudinal Stent Deformation</title>
          <description>Longitudinal stent deformation, evidenced by longitudinal compression or elongation, as the result of crossing a newly deployed stent with a second device, (such as a balloon catheter, stent system or IVUS catheter), causing the second device to become caught on the stent when the second device is advanced or retracted.</description>
          <units>percentage of stents</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="100"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Serious and non-serious adverse events were collected from the point of subject enrollment through study completion at 30 days.</time_frame>
      <group_list>
        <group group_id="E1">
          <title>NG PROMUS Stent</title>
          <description>Single-arm treatment group receiving interventional NG PROMUS study stent&#xD;
Percutaneous coronary intervention (NG PROMUS): Interventional coronary artery stenting with NG PROMUS study stent.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (12.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="16" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Coronary artery dissection</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Coronary artery stenosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Pericarditis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Non-cardiac chest pain</sub_title>
                <counts group_id="E1" events="7" subjects_affected="7" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Vascular pseudoaneurysm</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Costochondritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_vocab>MedDRA (12.1)</default_vocab>
        <default_assessment>Systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="27" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="16" subjects_affected="16" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Coronary artery dissection</sub_title>
                <counts group_id="E1" events="5" subjects_affected="5" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Bradycardia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Nausea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Catheter site haematoma</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Catheter site haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Procedural hypotension</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Skin laceration</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood urine present</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Musculoskeletal and connective tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Muscle spasms</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
              <event>
                <sub_title>Musculoskeletal pain</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Presyncope</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="100"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Skin and subcutaneous tissue disorders</title>
            <event_list>
              <event>
                <sub_title>Increased tendency to bruise</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="100"/>
              </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>Institution and Investigator shall have the right to publish the results, provided that before publishing, Institution and Investigator shall submit copies of any proposed publication or presentation to Sponsor for review at least sixty (60) days in advance of submission for publication or presentation to a publisher or other third party. Sponsor reserves the right to delete any confidential information or other proprietary information of Sponsor from the proposed publication or presentation.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Peter Maurer, Director Clinical Trials</name_or_title>
      <organization>Boston Scientific</organization>
      <phone>508-683-6678</phone>
      <email>Peter.Maurer@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/NCT01703000
org study id: NG PROMUS Clinical Trial S2294
nct id: NCT01703000
lead sponsor: 
has dmc: No
NG PROMUS: A Prospective, Multicenter Trial to Assess the NG PROMUS Everolimus-Eluting
      Platinum Chromium Coronary Stent System (NG PROMUS Stent System) for the Treatment of
      Atherosclerotic Lesion(s)
To evaluate clinical and peri-procedural angiographic and intravascular ultrasound (IVUS)
      outcomes for the NG PROMUS Everolimus-Eluting Platinum Chromium Coronary Stent System (NG
      PROMUS Stent System) in the treatment of subjects with atherosclerotic lesion(s) ≤ 34 mm in
      length (by visual estimate) in native coronary arteries ≥ 2.50 mm to ≤ 4.0 mm in diameter (by
      visual estimate)
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Technical Success Rate
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
description: Technical success is defined as successful delivery and deployment of the study stent to the target lesion, without balloon rupture or stent embolization, and post-procedure diameter stenosis of <30% assessed in 2 near-orthogonal projections with TIMI 3 flow in the target lesion, as visually assessed by the physician
measure: Target Lesion Revascularization (TLR) Rate
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
description: Target lesion revascularization is any ischemia-driven repeat percutaneous intervention, to improve blood flow, of the successfully treated target lesion or bypass surgery of the target vessel with a graft distally to the successfully treated target lesion. A TLR will be considered as ischemia-driven if the target lesion diameter stenosis is >/= 50% by QCA and there is presence of clinical or functional ischemia which cannot be explained by other coronary or graft lesions. Clinical or functional ischemia is any of the following:
The subject has a positive functional study corresponding to the area served by the target lesion.
The subject has ischemic ECG changes at rest in a distribution consistent with the target vessel.
The subject has ischemic symptoms referable to the target lesion. A TLR will be considered as ischemia-driven if the lesion diameter stenosis is >/= 70% by QCA even in the absence of clinical or functional ischemia.
measure: Target Lesion Failure (TLF) Rate
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
description: Target lesion failure is any ischemia-driven revascularization of the target lesion, MI (Q-wave and non-Q-wave) related to the target vessel, or (cardiac) death. For the purposes of this protocol, if it cannot be determined with certainty whether the MI was related to the target vessel, it will be considered a TLF.
The MI definition used for Target Lesion Failure was the PLATINUM MI definition.
measure: Target Vessel Revascularization (TVR) Rate
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
description: Target vessel revascularization is defined as a TLR or a TVR remote. Target vessel revascularization remote is any ischemia-driven repeat percutaneous intervention, to improve blood flow, or bypass surgery of not previously existing lesions diameter stenosis >/= 50% by QCA in the target vessel, excluding the target lesion. A TVR will be considered ischemia-driven if the target vessel diameter stenosis is >/= 50% by QCA and any of the following are present:
The subject has a positive functional study corresponding to the area served by the target vessel.
The subject has ischemic ECG changes at rest in a distribution consistent with the target vessel.
The subject has ischemic symptoms referable to the target vessel. A TVR will also be considered as ischemia-driven if the lesion diameter stenosis is >/=70% even in the absence of clinical or functional ischemia.
measure: Target Vessel Failure (TVF) Rate
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
description: Target vessel failure is any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or death related to the target vessel. For the purposes of this protocol, if it cannot be determined with certainty whether the MI or death was related to the target vessel, it will be considered a TVF.
The MI definition used was the PLATINUM MI definition.
measure: Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
description: MI will be defined according to the PLATINUM Definition of MI with evidence pre-specified for i) Spontaneous, ii) PCI-related, iii) CABG related, and iv) autopsy evidence criteria.
measure: Cardiac Death Rate
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
description: Cardiac death is defined as death due to any of the following.
Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
CVA through hospital discharge or CVA suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded
measure: Non-cardiac Death Rate
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
description: Non-cardiac death is defined as a death not due to any of the following:
Acute MI
Cardiac perforation/pericardial tamponade
Arrhythmia or conduction abnormality
CVA through hospital discharge or CVA suspected of being related to the procedure
Death due to complication of the procedure, including bleeding, vascular repair, transfusion reaction, or bypass surgery
Any death in which a cardiac cause cannot be excluded
measure: All Death Rate
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
description: Death is categorized as cardiac or non-cardiac deaths.
measure: Cardiac Death or MI Rate
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
description: Any cardiac death or MI event meeting the criteria defined for a cardiac death or MI.
MI definition used was the PLATINUM definition for MI.
measure: All Death or MI Rate
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
description: Any all-cause mortality event or MI meeting the criteria defined for any death or MI.
MI definition used was the PLATINUM definition for MI.
measure: All Death/MI/TVR Rate
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
description: Any event meeting the pre-specified criteria for any death, MI, or TVR.
MI definition used was the PLATINUM definition for MI.
measure: Stent Thrombosis Rate (by Academic Research Consortium [ARC] Definitions)
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day and at 30 days
description: Stent thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guide catheter has been removed and the patient left the catheterization lab.
Timing:
Acute stent thrombosis*: 0 24 hours after stent implantation
Subacute stent thrombosis*: >24 hours to 30 days after stent implantation
Late stent thrombosis: >30 days to 1 year after stent implantation
Very late stent thrombosis: >1 year after stent implantation * Acute/subacute can also be replaced by early stent thrombosis. Early stent thrombosis is 0 30 days.
Stent thrombosis may be defined as:
Confirmed/definite
Probable
Possible
Confirmed/Definite (is considered either angiographic confirmed or pathologic confirmed)
measure: Clinical Procedural Success Rate
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
description: Clinical procedural success is post-procedure diameter stenosis <30% in 2 near-orthogonal projections with TIMI 3 flow in all target lesions, as visually assessed by the physician, without the occurrence of in-hospital MI, TVR, or cardiac death.
MI definition used was the PLATINUM definition for MI.
measure: In-stent Percent Diameter Stenosis (%DS)
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
description: As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA), the % diameter stenosis of the in-stent region.
Percent diameter stenosis: Relative changes that occur in the percent diameter stenosis are provided by the following relationship: % diameter stenosis= (1-[Minimum Lumen Diameter/Reference diameter]) x 100.
measure: In-segment Percent Diameter Stenosis (%DS)
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
description: As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA), the % diameter stenosis of the in-segment region (in-segment includes the stented region and 5 mm edge regions).
Percent diameter stenosis: Relative changes that occur in the percent diameter stenosis are provided by the following relationship: % diameter stenosis= (1-[Minimum Lumen Diameter/Reference diameter]) x 100.
measure: In-stent Minimum Lumen Diameter (MLD)
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
description: As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA); the minimum lumen diameter (MLD) measured at the in-stent region.
The MLD is the mean minimum lumen diameter (mm) from 2 orthogonal views.
measure: In-segment Minimum Lumen Diameter (MLD)
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
description: As measured by an independent angiographic core laboratory using quantitative coronary angiography (QCA); the minimum lumen diameter (MLD) measured at the in-segment region (in-segment includes the stented region and 5 mm edge regions).
The MLD is the mean minimum lumen diameter (mm) from 2 orthogonal views.
measure: Acute Gain
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
description: Acute gain, as measured by angiographic core lab
measure: Vessel Area
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
description: As measured by IVUS, the mean vessel area (mm2).
measure: Stent Area
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
description: As measured by IVUS, the area of the stent.
measure: Lumen Area
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
description: As measured by IVUS, the area of the lumen.
measure: Vessel Volume
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
description: As measured by IVUS, the volume of the vessel.
measure: Stent Volume
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
description: As measured by IVUS, the volume of the stent.
measure: Lumen Volume
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
description: As measured by IVUS, the volume of the lumen.
measure: Incomplete Apposition
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
description: Incomplete apposition rate, as measured by the IVUS core lab.
Binary assessment of presence of one or more stent struts separated from the vessel wall as detected through intravascular ultrasound (IVUS).
measure: Percent Net Volume Obstruction
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
description: The percentage of volume obstruction, as measured by the IVUS core lab.
measure: Longitudinal Stent Deformation
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day
description: Longitudinal stent deformation, evidenced by longitudinal compression or elongation, as the result of crossing a newly deployed stent with a second device, (such as a balloon catheter, stent system or IVUS catheter), causing the second device to become caught on the stent when the second device is advanced or retracted.
arm group label: NG PROMUS stent
arm group type: Experimental
description: Single-arm treatment group receiving interventional NG PROMUS study stent
intervention type: Device
intervention name: Percutaneous coronary intervention (NG PROMUS)
description: Interventional coronary artery stenting with NG PROMUS study stent.
arm group label: NG PROMUS stent
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: John A Ormiston, MBChB, FRACP, FRACR
role: Principal Investigator
affiliation: Mercy Angiography Unit, Ltd. Mercy Hospital
facility: 
facility: 
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country: Australia
country: New Zealand
country: Singapore
url: http://www.pharma.us.novartis.com/info/products/name/zortress.jsp
description: Drug-eluting product information from Manufacturer
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Atherosclerosis
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 