<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/NCT02240810</url>
  </required_header>
  <id_info>
    <org_study_id>S2326</org_study_id>
    <nct_id>NCT02240810</nct_id>
  </id_info>
  <brief_title>PLATINUM Diversity</brief_title>
  <official_title>PLATINUM Diversity: Outcomes With the Promus PREMIER™ Stent in Women and Minorities (S2326)</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>
      To compile acute procedural performance and clinical outcomes data for the Promus PREMIER&#xD;
      everolimus-eluting coronary stent system in understudied/underserved patient populations&#xD;
      including women and minorities.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2014</start_date>
  <completion_date type="Actual">December 2016</completion_date>
  <primary_completion_date type="Actual">September 2016</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>12 Months</target_duration>
  <primary_outcome>
    <measure>Composite Rate of Death, Myocardial Infarction (MI), and Target Vessel Revascularization (TVR)</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months</time_frame>
    <description>A Clinical Events Committee (CEC), independent group of physician experts was used to evaluate all reported cases of death, MI, TVR to determine whether they met the specific protocol definition of the event. It is the CEC adjudicated result that is used in the endpoint analysis. Results for the PROMUS Element Plus study are reported in record NCT01589978</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Death</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months</time_frame>
    <description>A Clinical Events Committee (CEC), independent group of physician experts was used to evaluate all reported cases of death to determine whether they met the specific protocol definition of the event. It is the CEC adjudicated result that is used in the endpoint analysis. Results for the PROMUS Element Plus study are reported in record NCT01589978</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial Infarction (MI)</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months</time_frame>
    <description>A Clinical Events Committee (CEC), independent group of physician experts was used to evaluate all reported cases of MI to determine whether they met the specific protocol definition of the event. It is the CEC adjudicated result that is used in the endpoint analysis. Results for the PROMUS Element Plus study are reported in record NCT01589978</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target Vessel Revascularization (TVR)</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months</time_frame>
    <description>A Clinical Events Committee (CEC), independent group of physician experts was used to evaluate all reported cases of TVR to determine whether they met the specific protocol definition of the event. It is the CEC adjudicated result that is used in the endpoint analysis. Results for the PROMUS Element Plus study are reported in record NCT01589978</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">1501</enrollment>
  <condition>Atherosclerosis</condition>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>PLATINUM Diversity (Overall)</arm_group_label>
    <description>PLATINUM Diversity (Overall) population. Test device is Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System (CSS)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Percutaneous coronary intervention (Promus PREMIER)</intervention_name>
    <description>Interventional coronary artery stenting with Promus PREMIER study stent.</description>
    <arm_group_label>PLATINUM Diversity (Overall)</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Population will be selected from clinical locations where subjects are treated with at&#xD;
        least one Promus PREMIER everolimus-eluting coronary stent.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient must be at least 18 years of age&#xD;
&#xD;
          -  Patient must sign informed consent form&#xD;
&#xD;
          -  Patient has received at least one Promus PREMIER stent&#xD;
&#xD;
          -  Patient self-identifies as one or more of the following:&#xD;
&#xD;
               -  Female&#xD;
&#xD;
               -  Black of African Heritage&#xD;
&#xD;
               -  Hispanic/Latino&#xD;
&#xD;
               -  American Indian or Alaska native&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not applicable&#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>Roxana Mehran, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Icahn School of Medicine at Mount Sinai</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Wayne Batchelor, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tallahassee Memorial Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>St Luke's Medical Center</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85006</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Bernards Heart and Vascular</name>
      <address>
        <city>Jonesboro</city>
        <state>Arkansas</state>
        <zip>72401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Arkansas Cardiology/Baptist Health Medical Center</name>
      <address>
        <city>Little Rock</city>
        <state>Arkansas</state>
        <zip>72205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Central Cardiology Medical Clinic</name>
      <address>
        <city>Bakersfield</city>
        <state>California</state>
        <zip>93308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sharp Chula Vista Medical Center</name>
      <address>
        <city>Chula Vista</city>
        <state>California</state>
        <zip>91911</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Consultants Heart Center</name>
      <address>
        <city>Fresno</city>
        <state>California</state>
        <zip>93720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UCLA Medical Center</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mercy General Hospital</name>
      <address>
        <city>Sacramento</city>
        <state>California</state>
        <zip>95189</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Capital Research Institute</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20017</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bay Area Cardiology</name>
      <address>
        <city>Brandon</city>
        <state>Florida</state>
        <zip>33511</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Research Physicians Network Alliance</name>
      <address>
        <city>Hollywood</city>
        <state>Florida</state>
        <zip>33021</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Memorial Hospital Jacksonville</name>
      <address>
        <city>Jacksonville</city>
        <state>Florida</state>
        <zip>32216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Institute of Northwest Florida</name>
      <address>
        <city>Panama City</city>
        <state>Florida</state>
        <zip>32401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Charlotte Heart &amp; Vascular</name>
      <address>
        <city>Port Charlotte</city>
        <state>Florida</state>
        <zip>33592</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Tallahassee Memorial Hospital</name>
      <address>
        <city>Tallahassee</city>
        <state>Florida</state>
        <zip>32308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pepin Heart Hospital and Dr. Kiran C. Patel Research Institute</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Emory University</name>
      <address>
        <city>Atlanta</city>
        <state>Georgia</state>
        <zip>30308</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital</name>
      <address>
        <city>Augusta</city>
        <state>Georgia</state>
        <zip>30901</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Redmond Regional Medical Center</name>
      <address>
        <city>Rome</city>
        <state>Georgia</state>
        <zip>30165</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Chicago Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60637</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Presence Saint Joseph Medical Center</name>
      <address>
        <city>Joliet</city>
        <state>Illinois</state>
        <zip>60435</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Heart Center of Lake County</name>
      <address>
        <city>Merrillville</city>
        <state>Indiana</state>
        <zip>46410</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Iowa Hospitals and Clinics</name>
      <address>
        <city>Iowa City</city>
        <state>Iowa</state>
        <zip>52242</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiovascular Research, LLC (Willis-Knighton)</name>
      <address>
        <city>Shreveport</city>
        <state>Louisiana</state>
        <zip>71005</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>MedStar Union Memorial Hospital</name>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21218</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Suburban Hospital</name>
      <address>
        <city>Bethesda</city>
        <state>Maryland</state>
        <zip>20814</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Delmarva Heart Research Foundation</name>
      <address>
        <city>Salisbury</city>
        <state>Maryland</state>
        <zip>21804</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Baystate Medical Center</name>
      <address>
        <city>Springfield</city>
        <state>Massachusetts</state>
        <zip>01199</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CCA Research</name>
      <address>
        <city>Gulfport</city>
        <state>Mississippi</state>
        <zip>39503</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>North Kansas City Hospital</name>
      <address>
        <city>North Kansas City</city>
        <state>Missouri</state>
        <zip>64116</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Louis Heart and Vascular</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63136</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Jersey Shore University Medical Center</name>
      <address>
        <city>Neptune</city>
        <state>New Jersey</state>
        <zip>07753</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Montefiore Medical Center</name>
      <address>
        <city>Bronx</city>
        <state>New York</state>
        <zip>10467</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Mount Sinai Hospital</name>
      <address>
        <city>New York</city>
        <state>New York</state>
        <zip>10029</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Novant Health Heart and Vascular Institute</name>
      <address>
        <city>Charlotte</city>
        <state>North Carolina</state>
        <zip>28204</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>NC Heart and Vascular Research</name>
      <address>
        <city>Raleigh</city>
        <state>North Carolina</state>
        <zip>27610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>INTEGRIS Baptist Medical Center</name>
      <address>
        <city>Oklahoma City</city>
        <state>Oklahoma</state>
        <zip>73112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Presbyterian University Hospital</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lankenau Medical Center</name>
      <address>
        <city>Wynnewood</city>
        <state>Pennsylvania</state>
        <zip>19096</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Palmetto Health</name>
      <address>
        <city>Columbia</city>
        <state>South Carolina</state>
        <zip>29203</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Francis Physician Services Inc., DBA Upstate Cardiology</name>
      <address>
        <city>Greenville</city>
        <state>South Carolina</state>
        <zip>29607</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Seton Heart Institute</name>
      <address>
        <city>Austin</city>
        <state>Texas</state>
        <zip>78705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Methodist Hospital Dallas</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75208</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>VA North Texas Health Care System</name>
      <address>
        <city>Dallas</city>
        <state>Texas</state>
        <zip>75216</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Plaza Medical Center of Forth Worth</name>
      <address>
        <city>Fort Worth</city>
        <state>Texas</state>
        <zip>76104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Medical Branch at Galveston</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77555</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Luke's Episcopal Hospital</name>
      <address>
        <city>Houston</city>
        <state>Texas</state>
        <zip>77030</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Christus Santa Rosa Hospital-City Center</name>
      <address>
        <city>New Braunfels</city>
        <state>Texas</state>
        <zip>78130</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The University of Vermont Medical Center</name>
      <address>
        <city>Burlington</city>
        <state>Vermont</state>
        <zip>05401</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Virginia Mason</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98101</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiac Study Center</name>
      <address>
        <city>Tacoma</city>
        <state>Washington</state>
        <zip>98405</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CAMC Clinical Trials Center</name>
      <address>
        <city>Charleston</city>
        <state>West Virginia</state>
        <zip>25304</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Batchelor W, Kandzari DE, Davis S, Tami L, Wang JC, Othman I, Gigliotti OS, Haghighat A, Singh S, Lopez M, Giugliano G, Horwitz PA, Chandrasekhar J, Underwood P, Thompson CA, Mehran R. Outcomes in Women and Minorities Compared With White Men 1 Year After Everolimus-Eluting Stent Implantation: Insights and Results From the PLATINUM Diversity and PROMUS Element Plus Post-Approval Study Pooled Analysis. JAMA Cardiol. 2017 Dec 1;2(12):1303-1313. doi: 10.1001/jamacardio.2017.3802.</citation>
    <PMID>29049508</PMID>
  </reference>
  <verification_date>May 2019</verification_date>
  <study_first_submitted>September 10, 2014</study_first_submitted>
  <study_first_submitted_qc>September 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 16, 2014</study_first_posted>
  <results_first_submitted>July 11, 2017</results_first_submitted>
  <results_first_submitted_qc>May 9, 2019</results_first_submitted_qc>
  <results_first_posted type="Actual">May 10, 2019</results_first_posted>
  <last_update_submitted>May 13, 2019</last_update_submitted>
  <last_update_submitted_qc>May 13, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">May 15, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <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>PLATINUM Diversity and PROMUS Element Plus US Post Approval study (PE Plus) are two separate studies that have been pooled.&#xD;
Only the PLATINUM Diversity subjects (n=1501) are considered to be enrolled in the study. Results for the PROMUS Element Plus study are reported in record NCT01589978</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>PLATINUM Diversity (Overall)</title>
          <description>Percutaneous coronary intervention (Promus PREMIER): Interventional coronary artery stenting with Promus PREMIER study stent.&#xD;
Overall population.</description>
        </group>
        <group group_id="P2">
          <title>PROMUS Element Plus US Post Approval Study</title>
          <description>PROMUS Element Plus US Post Approval Study</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="1501"/>
                <participants group_id="P2" count="2681">correct typo</participants>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="1441"/>
                <participants group_id="P2" count="2621"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="60"/>
                <participants group_id="P2" count="60"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>PLATINUM Diversity (Overall)</title>
          <description>Percutaneous coronary intervention (Promus PREMIER): Interventional coronary artery stenting with Promus PREMIER study stent.&#xD;
Overall population.</description>
        </group>
        <group group_id="B2">
          <title>PROMUS Element Plus US Post Approval Study (Overall)</title>
          <description>PROMUS Element Plus US Post Approval Study&#xD;
NOTE: Results for the PROMUS Element Plus study are reported in record NCT01589978</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="1501"/>
            <count group_id="B2" value="2681"/>
            <count group_id="B3" value="4182"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>18 Years and Older</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1501"/>
                    <measurement group_id="B2" value="2681"/>
                    <measurement group_id="B3" value="4182"/>
                  </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="1057"/>
                    <measurement group_id="B2" value="807"/>
                    <measurement group_id="B3" value="1864"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="444"/>
                    <measurement group_id="B2" value="1874"/>
                    <measurement group_id="B3" value="2318"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <description>NOTE: Patients were able to self-identify as more than one racial/ethnic category</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>American Indian or Alaska Native</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                    <measurement group_id="B2" value="14"/>
                    <measurement group_id="B3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Black, of African Heritage</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="483"/>
                    <measurement group_id="B2" value="189"/>
                    <measurement group_id="B3" value="672"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Caucasian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="733"/>
                    <measurement group_id="B2" value="2318"/>
                    <measurement group_id="B3" value="3051"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Hispanic or Latino</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="260"/>
                    <measurement group_id="B2" value="95"/>
                    <measurement group_id="B3" value="355"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Native Hawaiian or Other Pacific Islander</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="13"/>
                    <measurement group_id="B2" value="20"/>
                    <measurement group_id="B3" value="33"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Not Disclosed</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="37"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1501"/>
                    <measurement group_id="B2" value="2681"/>
                    <measurement group_id="B3" value="4182"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants with Current Diabetes Mellitus</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Current Diabetes Mellitus</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="676"/>
                    <measurement group_id="B2" value="989"/>
                    <measurement group_id="B3" value="1665"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 1</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="49"/>
                    <measurement group_id="B3" value="76"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Type 2</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="608"/>
                    <measurement group_id="B2" value="902"/>
                    <measurement group_id="B3" value="1510"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Unknown</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="41"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="79"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants with History of Hyperlipidemia Requiring Medication</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1107"/>
                    <measurement group_id="B2" value="2016"/>
                    <measurement group_id="B3" value="3123"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants with History of Hypertension Requiring Medication</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1275"/>
                    <measurement group_id="B2" value="2077"/>
                    <measurement group_id="B3" value="3352"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants with Family History of Coronary Artery Disease (CAD)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="839"/>
                    <measurement group_id="B2" value="1625"/>
                    <measurement group_id="B3" value="2464"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants with History of Myocardial Infarction (MI)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="450"/>
                    <measurement group_id="B2" value="1409"/>
                    <measurement group_id="B3" value="1859"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants with History of Congestive Heart Failure (CHF)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="215"/>
                    <measurement group_id="B2" value="275"/>
                    <measurement group_id="B3" value="490"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants with History of Percutaneous Coronary Intervention (PCI)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="607"/>
                    <measurement group_id="B2" value="1159"/>
                    <measurement group_id="B3" value="1766"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants with History of Coronary Artery Bypass Graft (CABG)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="205"/>
                    <measurement group_id="B2" value="457"/>
                    <measurement group_id="B3" value="662"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants with History of Renal Disease</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="248"/>
                    <measurement group_id="B2" value="283"/>
                    <measurement group_id="B3" value="531"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants with History of Peripheral Vascular Disease (PVD)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="175"/>
                    <measurement group_id="B2" value="299"/>
                    <measurement group_id="B3" value="474"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Number of Participants with History of Multivessel Disease</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>History of Multivessel Disease</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="537"/>
                    <measurement group_id="B2" value="1151"/>
                    <measurement group_id="B3" value="1688"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>2-Vessel</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="252"/>
                    <measurement group_id="B2" value="NA">Not assessed as part of this study</measurement>
                    <measurement group_id="B3" value="NA">Total not calculated because data are not available (NA) in one or more arms.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>3-Vessel</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="285"/>
                    <measurement group_id="B2" value="NA">Not assessed as part of this study</measurement>
                    <measurement group_id="B3" value="NA">Total not calculated because data are not available (NA) in one or more arms.</measurement>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Smoking Status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Current</title>
                  <measurement_list>
                    <measurement group_id="B1" value="331"/>
                    <measurement group_id="B2" value="610"/>
                    <measurement group_id="B3" value="941"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Never</title>
                  <measurement_list>
                    <measurement group_id="B1" value="603"/>
                    <measurement group_id="B2" value="1021"/>
                    <measurement group_id="B3" value="1624"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Previous</title>
                  <measurement_list>
                    <measurement group_id="B1" value="545"/>
                    <measurement group_id="B2" value="990"/>
                    <measurement group_id="B3" value="1535"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="22"/>
                    <measurement group_id="B2" value="60"/>
                    <measurement group_id="B3" value="82"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Composite Rate of Death, Myocardial Infarction (MI), and Target Vessel Revascularization (TVR)</title>
        <description>A Clinical Events Committee (CEC), independent group of physician experts was used to evaluate all reported cases of death, MI, TVR to determine whether they met the specific protocol definition of the event. It is the CEC adjudicated result that is used in the endpoint analysis. Results for the PROMUS Element Plus study are reported in record NCT01589978</description>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months</time_frame>
        <population>the outcome measure is the count of individuals that had a CEC event within 365 days post-procedure. The percentage is calculated based on the count over the denominator (patients who have had any CEC events within 365 days post-procedure or who were event-free with the last follow-up at least 335 days post-procedure).</population>
        <group_list>
          <group group_id="O1">
            <title>PLATINUM Diversity (Overall)</title>
            <description>Percutaneous coronary intervention (Promus PREMIER): Interventional coronary artery stenting with Promus PREMIER study stent.&#xD;
Overall population.</description>
          </group>
          <group group_id="O2">
            <title>Caucasian Males - PROMUS Element Plus US Post Approval Study</title>
            <description>Caucasian males enrolled in the PROMUS Element Plus US Post Approval Study</description>
          </group>
          <group group_id="O3">
            <title>Females - PLATINUM Diversity and PE+</title>
            <description>All females enrolled in both the PLATINUM Diversity study and PROMUS Element Plus US Post Approval Study.</description>
          </group>
          <group group_id="O4">
            <title>Minorities - PLATINUM Diversity and PE+</title>
            <description>All minorities enrolled in both the PLATINUM Diversity study and PROMUS Element Plus US Post Approval Study</description>
          </group>
        </group_list>
        <measure>
          <title>Composite Rate of Death, Myocardial Infarction (MI), and Target Vessel Revascularization (TVR)</title>
          <description>A Clinical Events Committee (CEC), independent group of physician experts was used to evaluate all reported cases of death, MI, TVR to determine whether they met the specific protocol definition of the event. It is the CEC adjudicated result that is used in the endpoint analysis. Results for the PROMUS Element Plus study are reported in record NCT01589978</description>
          <population>the outcome measure is the count of individuals that had a CEC event within 365 days post-procedure. The percentage is calculated based on the count over the denominator (patients who have had any CEC events within 365 days post-procedure or who were event-free with the last follow-up at least 335 days post-procedure).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1479"/>
                <count group_id="O2" value="1569"/>
                <count group_id="O3" value="1808"/>
                <count group_id="O4" value="1029"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="128"/>
                    <measurement group_id="O2" value="120"/>
                    <measurement group_id="O3" value="155"/>
                    <measurement group_id="O4" value="99"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Death</title>
        <description>A Clinical Events Committee (CEC), independent group of physician experts was used to evaluate all reported cases of death to determine whether they met the specific protocol definition of the event. It is the CEC adjudicated result that is used in the endpoint analysis. Results for the PROMUS Element Plus study are reported in record NCT01589978</description>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months</time_frame>
        <population>the outcome measure is the count of individuals that had a CEC event within 365 days post-procedure. The percentage is calculated based on the count over the denominator (patients who have had any CEC events within 365 days post-procedure or who were event-free with the last follow-up at least 335 days post-procedure).</population>
        <group_list>
          <group group_id="O1">
            <title>PLATINUM Diversity (Overall)</title>
            <description>Percutaneous coronary intervention (Promus PREMIER): Interventional coronary artery stenting with Promus PREMIER study stent.&#xD;
Overall population.</description>
          </group>
          <group group_id="O2">
            <title>Caucasian Males - PROMUS Element Plus US Post Approval Study</title>
            <description>Caucasian males enrolled in the PROMUS Element Plus US Post Approval Study</description>
          </group>
          <group group_id="O3">
            <title>Females - PLATINUM Diversity and PE+</title>
            <description>All females enrolled in both the PLATINUM Diversity study and PROMUS Element Plus US Post Approval Study.</description>
          </group>
          <group group_id="O4">
            <title>Minorities - PLATINUM Diversity and PE+</title>
            <description>All minorities enrolled in both the PLATINUM Diversity study and PROMUS Element Plus US Post Approval Study</description>
          </group>
        </group_list>
        <measure>
          <title>Death</title>
          <description>A Clinical Events Committee (CEC), independent group of physician experts was used to evaluate all reported cases of death to determine whether they met the specific protocol definition of the event. It is the CEC adjudicated result that is used in the endpoint analysis. Results for the PROMUS Element Plus study are reported in record NCT01589978</description>
          <population>the outcome measure is the count of individuals that had a CEC event within 365 days post-procedure. The percentage is calculated based on the count over the denominator (patients who have had any CEC events within 365 days post-procedure or who were event-free with the last follow-up at least 335 days post-procedure).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1479"/>
                <count group_id="O2" value="1569"/>
                <count group_id="O3" value="1808"/>
                <count group_id="O4" value="1029"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="60"/>
                    <measurement group_id="O2" value="35"/>
                    <measurement group_id="O3" value="62"/>
                    <measurement group_id="O4" value="38"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Myocardial Infarction (MI)</title>
        <description>A Clinical Events Committee (CEC), independent group of physician experts was used to evaluate all reported cases of MI to determine whether they met the specific protocol definition of the event. It is the CEC adjudicated result that is used in the endpoint analysis. Results for the PROMUS Element Plus study are reported in record NCT01589978</description>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months</time_frame>
        <population>The outcome measure is the count of individuals that had a CEC event within 365 days post-procedure. The percentage is calculated based on the count over the denominator (patients who have had any CEC events within 365 days post-procedure or who were event-free with the last follow-up at least 335 days post-procedure).</population>
        <group_list>
          <group group_id="O1">
            <title>PLATINUM Diversity (Overall)</title>
            <description>Percutaneous coronary intervention (Promus PREMIER): Interventional coronary artery stenting with Promus PREMIER study stent.&#xD;
Overall population.</description>
          </group>
          <group group_id="O2">
            <title>Caucasian Males - PROMUS Element Plus US Post Approval Study</title>
            <description>Caucasian males enrolled in the PROMUS Element Plus US Post Approval Study</description>
          </group>
          <group group_id="O3">
            <title>Females - PLATINUM Diversity and PE+</title>
            <description>All females enrolled in both the PLATINUM Diversity study and PROMUS Element Plus US Post Approval Study.</description>
          </group>
          <group group_id="O4">
            <title>Minorities - PLATINUM Diversity and PE+</title>
            <description>All minorities enrolled in both the PLATINUM Diversity study and PROMUS Element Plus US Post Approval Study</description>
          </group>
        </group_list>
        <measure>
          <title>Myocardial Infarction (MI)</title>
          <description>A Clinical Events Committee (CEC), independent group of physician experts was used to evaluate all reported cases of MI to determine whether they met the specific protocol definition of the event. It is the CEC adjudicated result that is used in the endpoint analysis. Results for the PROMUS Element Plus study are reported in record NCT01589978</description>
          <population>The outcome measure is the count of individuals that had a CEC event within 365 days post-procedure. The percentage is calculated based on the count over the denominator (patients who have had any CEC events within 365 days post-procedure or who were event-free with the last follow-up at least 335 days post-procedure).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1479"/>
                <count group_id="O2" value="1569"/>
                <count group_id="O3" value="1808"/>
                <count group_id="O4" value="1029"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38"/>
                    <measurement group_id="O2" value="17"/>
                    <measurement group_id="O3" value="34"/>
                    <measurement group_id="O4" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Target Vessel Revascularization (TVR)</title>
        <description>A Clinical Events Committee (CEC), independent group of physician experts was used to evaluate all reported cases of TVR to determine whether they met the specific protocol definition of the event. It is the CEC adjudicated result that is used in the endpoint analysis. Results for the PROMUS Element Plus study are reported in record NCT01589978</description>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months</time_frame>
        <population>The outcome measure is the count of individuals that had a CEC event within 365 days post-procedure. The percentage is calculated based on the count over the denominator (patients who have had any CEC events within 365 days post-procedure or who were event-free with the last follow-up at least 335 days post-procedure).</population>
        <group_list>
          <group group_id="O1">
            <title>PLATINUM Diversity (Overall)</title>
            <description>Percutaneous coronary intervention (Promus PREMIER): Interventional coronary artery stenting with Promus PREMIER study stent.&#xD;
Overall population.</description>
          </group>
          <group group_id="O2">
            <title>Caucasian Males - PROMUS Element Plus US Post Approval Study</title>
            <description>Caucasian males enrolled in the PROMUS Element Plus US Post Approval Study</description>
          </group>
          <group group_id="O3">
            <title>Females - PLATINUM Diversity and PE+</title>
            <description>All females enrolled in both the PLATINUM Diversity study and PROMUS Element Plus US Post Approval Study.</description>
          </group>
          <group group_id="O4">
            <title>Minorities - PLATINUM Diversity and PE+</title>
            <description>All minorities enrolled in both the PLATINUM Diversity study and PROMUS Element Plus US Post Approval Study</description>
          </group>
        </group_list>
        <measure>
          <title>Target Vessel Revascularization (TVR)</title>
          <description>A Clinical Events Committee (CEC), independent group of physician experts was used to evaluate all reported cases of TVR to determine whether they met the specific protocol definition of the event. It is the CEC adjudicated result that is used in the endpoint analysis. Results for the PROMUS Element Plus study are reported in record NCT01589978</description>
          <population>The outcome measure is the count of individuals that had a CEC event within 365 days post-procedure. The percentage is calculated based on the count over the denominator (patients who have had any CEC events within 365 days post-procedure or who were event-free with the last follow-up at least 335 days post-procedure).</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="1479"/>
                <count group_id="O2" value="1569"/>
                <count group_id="O3" value="1808"/>
                <count group_id="O4" value="1029"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="58"/>
                    <measurement group_id="O2" value="86"/>
                    <measurement group_id="O3" value="84"/>
                    <measurement group_id="O4" value="56"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>1 year</time_frame>
      <desc>Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978.&#xD;
Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total.&#xD;
Adverse Events were assessed at each scheduled study follow-up with participants.</desc>
      <group_list>
        <group group_id="E1">
          <title>PLATINUM Diversity (Overall)</title>
          <description>Percutaneous coronary intervention (Promus PREMIER): Interventional coronary artery stenting with Promus PREMIER study stent.&#xD;
Overall adverse event data were only analyzed for the PLATINUM Diversity Study. Adverse events for the PROMUS Element Plus study are reported in record NCT01589978.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (Unspecified)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="60" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="154" subjects_at_risk="1501"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Acute myocardial infarction</sub_title>
                <assessment>Systematic Assessment</assessment>
                <description>Multiple Serious Adverse Events may be experienced by the same study Subjects. The total number of participants affected by all adverse events will not be consistent with Total.</description>
                <counts group_id="E1" events="49" subjects_affected="42" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="26" subjects_affected="24" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Coronary artery thrombosis</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="17" subjects_affected="16" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="10" subjects_affected="10" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Coronary artery dissection</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Cardiac arrest</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="8" subjects_affected="8" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Cardio-respiratory arrest</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Acute coronary syndrome</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Cardiac failure</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Coronary artery disease</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Ventricular fibrillation</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Aortic valve stenosis</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Arteriosclerosis coronary artery</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Cardiac failure congestive</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Cardiogenic shock</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Electromechanical dissociation</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Ischaemic cardiomyopathy</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Postinfarction angina</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Ventricular tachycardia</sub_title>
                <assessment>Systematic Assessment</assessment>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1501"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Intestinal ischaemia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1501"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Death</sub_title>
                <counts group_id="E1" events="6" subjects_affected="6" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Drowning</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1501"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Septic shock</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Pneumonia</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1501"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>In-stent coronary artery restenosis</sub_title>
                <counts group_id="E1" events="14" subjects_affected="12" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Post procedural myocardial infarction</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Coronary artery restenosis</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1501"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Troponin increased</sub_title>
                <counts group_id="E1" events="3" subjects_affected="3" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Blood creatine phosphokinase MB increased</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Cardiac enzymes increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Troponin I increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1501"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Neoplasms benign, malignant and unspecified (incl cysts and polyps)</title>
            <event_list>
              <event>
                <sub_title>Lung cancer metastatic</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Lung neoplasm malignant</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Lung squamous cell carcinoma stage unspecified</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Lymphoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Metastases to peritoneum</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Ovarian cancer</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1501"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Cerebral haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Cerebral infarction</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Cerebrovascular accident</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Haemorrhage intracranial</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1501"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Renal and urinary disorders</title>
            <event_list>
              <event>
                <sub_title>Renal failure chronic</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Renal failure acute</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1501"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Respiratory, thoracic and mediastinal disorders</title>
            <event_list>
              <event>
                <sub_title>Respiratory failure</sub_title>
                <counts group_id="E1" events="2" subjects_affected="2" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Acute respiratory failure</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Chronic obstructive pulmonary disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Pulmonary fibrosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1501"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Vascular disorders</title>
            <event_list>
              <event>
                <sub_title>Aortic intramural haematoma</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Arteriosclerosis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1501"/>
              </event>
              <event>
                <sub_title>Peripheral arterial occlusive disease</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="1501"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>1</frequency_threshold>
        <default_vocab>MedDRA (Unspecified)</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="26" subjects_at_risk="1501"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Myocardial infarction</sub_title>
                <counts group_id="E1" events="26" subjects_affected="26" subjects_at_risk="1501"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>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/NCT02240810
org study id: S2326
nct id: NCT02240810
lead sponsor: 
has dmc: No
To compile acute procedural performance and clinical outcomes data for the Promus PREMIER
      everolimus-eluting coronary stent system in understudied/underserved patient populations
      including women and minorities.
observational model: Cohort
time perspective: Prospective
measure: Composite Rate of Death, Myocardial Infarction (MI), and Target Vessel Revascularization (TVR)
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months
description: A Clinical Events Committee (CEC), independent group of physician experts was used to evaluate all reported cases of death, MI, TVR to determine whether they met the specific protocol definition of the event. It is the CEC adjudicated result that is used in the endpoint analysis. Results for the PROMUS Element Plus study are reported in record NCT01589978
measure: Death
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months
description: A Clinical Events Committee (CEC), independent group of physician experts was used to evaluate all reported cases of death to determine whether they met the specific protocol definition of the event. It is the CEC adjudicated result that is used in the endpoint analysis. Results for the PROMUS Element Plus study are reported in record NCT01589978
measure: Myocardial Infarction (MI)
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months
description: A Clinical Events Committee (CEC), independent group of physician experts was used to evaluate all reported cases of MI to determine whether they met the specific protocol definition of the event. It is the CEC adjudicated result that is used in the endpoint analysis. Results for the PROMUS Element Plus study are reported in record NCT01589978
measure: Target Vessel Revascularization (TVR)
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, through 12 months
description: A Clinical Events Committee (CEC), independent group of physician experts was used to evaluate all reported cases of TVR to determine whether they met the specific protocol definition of the event. It is the CEC adjudicated result that is used in the endpoint analysis. Results for the PROMUS Element Plus study are reported in record NCT01589978
arm group label: PLATINUM Diversity (Overall)
description: PLATINUM Diversity (Overall) population. Test device is Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System (CSS)
intervention type: Device
intervention name: Percutaneous coronary intervention (Promus PREMIER)
description: Interventional coronary artery stenting with Promus PREMIER study stent.
arm group label: PLATINUM Diversity (Overall)
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Roxana Mehran, MD
role: Principal Investigator
affiliation: Icahn School of Medicine at Mount Sinai
last name: Wayne Batchelor, MD
role: Principal Investigator
affiliation: Tallahassee Memorial Hospital
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country: United States
citation: Batchelor W, Kandzari DE, Davis S, Tami L, Wang JC, Othman I, Gigliotti OS, Haghighat A, Singh S, Lopez M, Giugliano G, Horwitz PA, Chandrasekhar J, Underwood P, Thompson CA, Mehran R. Outcomes in Women and Minorities Compared With White Men 1 Year After Everolimus-Eluting Stent Implantation: Insights and Results From the PLATINUM Diversity and PROMUS Element Plus Post-Approval Study Pooled Analysis. JAMA Cardiol. 2017 Dec 1;2(12):1303-1313. doi: 10.1001/jamacardio.2017.3802.
PMID: 29049508
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Atherosclerosis
participant flow: 
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