<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/NCT02230254</url>
  </required_header>
  <id_info>
    <org_study_id>S2323</org_study_id>
    <nct_id>NCT02230254</nct_id>
  </id_info>
  <brief_title>PE PREMIER CHINA CLINICAL TRIAL</brief_title>
  <official_title>PE PREMIER China: A Prospective, Multicenter Trial to Assess the Promus PREMIER Everolimus-Eluting Platinum Chromium Coronary 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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      PE PREMIER China: A Prospective, Multicenter Trial to Assess the Promus PREMIERTM&#xD;
      Everolimus-Eluting Platinum Chromium Coronary Stent System for the Treatment of&#xD;
      Atherosclerotic Lesion(s)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To evaluate clinical and peri-procedural angiographic outcomes for the Promus PREMIERTM&#xD;
      Everolimus-Eluting Platinum Chromium Coronary Stent System in the treatment of subjects with&#xD;
      atherosclerotic lesion(s) ≤34 mm in length (by visual estimate) in native coronary arteries&#xD;
      ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate)&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 9, 2014</start_date>
  <completion_date type="Actual">July 31, 2015</completion_date>
  <primary_completion_date type="Actual">June 22, 2014</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 rate, 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, at 30 days, 6months and 12months</time_frame>
  </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, at 30 days, 6months and 12months</time_frame>
  </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, at 30 days, 6month and 12months</time_frame>
  </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, at 30 days, 6months and 12months</time_frame>
  </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, at 30 days, 6months and 12months</time_frame>
  </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, at 30 days, 6months and 12months</time_frame>
  </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, at 30 days, 6months and 12months</time_frame>
  </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, at 30 days, 6months and 12months</time_frame>
  </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, at 30 days, 6months and 12months</time_frame>
  </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, at 30 days, 6months and 12months</time_frame>
  </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, at 30 days, 6months and 12months</time_frame>
  </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, at 30 days, 6months and 12months</time_frame>
  </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, at 30 days, 6months and 12months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-stent and 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, at 30 days, 6months and 12months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-stent and 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, at 30 days, 6months and 12months</time_frame>
  </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, at 30 days, 6months and 12months</time_frame>
    <description>as measured by angiographic core lab, change from baseline for target lesions</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Longitudinal Stent Deformation (LSD) Rate</measure>
    <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">101</enrollment>
  <condition>Atherosclerosis</condition>
  <arm_group>
    <arm_group_label>PROMUS POREMIER stent</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Single-arm treatment group receiving interventional PROMUS PRIMIER study stent</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Percutaneous coronary intervention PROMUS PREMIER</intervention_name>
    <description>PROMUS PREMIER</description>
    <arm_group_label>PROMUS POREMIER stent</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical Inclusion (CI) Criteria&#xD;
&#xD;
        CI1. Subject must be at least 18 -75 years of age&#xD;
&#xD;
        CI2. 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;
        CI3. Subject is eligible for percutaneous coronary intervention (PCI)&#xD;
&#xD;
        CI4. Subject has symptomatic coronary artery disease with objective evidence of ischemia or&#xD;
        silent ischemia&#xD;
&#xD;
        CI5. Subject is an acceptable candidate for coronary artery bypass grafting (CABG)&#xD;
&#xD;
        CI6. Subject is willing to comply with all protocol-required follow-up evaluation&#xD;
&#xD;
        CI7. Subject has a left ventricular ejection fraction (LVEF) &gt;30% as measured within 60&#xD;
        days prior to enrollment&#xD;
&#xD;
          -  Angiographic Inclusion (AI) Criteria (visual estimate)&#xD;
&#xD;
        AI1. Target lesion(s) must be located in a native coronary artery with a visually estimated&#xD;
        reference vessel diameter (RVD) ≥2.25 mm and ≤4.0 mm&#xD;
&#xD;
        AI2. Target lesion(s) length must be ≤34 mm ( Target lesion(s) length must be ≤28 mm for&#xD;
        reference vessel diameter (RVD) = 2.25 mm Target lesion(s)) (by visual estimate)&#xD;
&#xD;
        AI3. 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 (stenosis&#xD;
        ≥70%, abnormal fractional flow reserve (FFR), abnormal stress test or imaging stress test,&#xD;
        or elevated biomarkers) prior to procedure&#xD;
&#xD;
        AI4. Coronary anatomy is likely to allow delivery of a study device to the target&#xD;
        lesions(s)&#xD;
&#xD;
        AI5. The first lesion treated must be successfully pre-dilated/pretreated Note: Successful&#xD;
        pre-dilatation/pretreatment refers to dilatation with a balloon catheter of appropriate&#xD;
        length and diameter, or pretreatment with/or rotational coronary atherectomy, or&#xD;
        cutting/scoring balloon with no greater than 50% residual stenosis and no dissection&#xD;
        greater than National Heart, Lung, Blood Institute (NHLBI) type C.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical Exclusion (CE) Criteria&#xD;
&#xD;
        CE1. Subject has clinical symptoms and/or electrocardiogram (ECG) changes consistent with&#xD;
        Acute MI (include STEMI and Non- STEMI ) within 1 week&#xD;
&#xD;
        CE2. Subject has cardiogenic shock, hemodynamic instability requiring inotropic or&#xD;
        mechanical circulatory support, intractable ventricular arrhythmias, or ongoing intractable&#xD;
        angina&#xD;
&#xD;
        CE3. Subject has received an organ transplant or is on a waiting list for an organ&#xD;
        transplant&#xD;
&#xD;
        CE4. Subject is receiving or scheduled to receive chemotherapy within 30 days before or&#xD;
        after the index procedure&#xD;
&#xD;
        CE5. Planned PCI (including staged procedures) or CABG after the index procedure&#xD;
&#xD;
        CE6. Subject previously treated at any time with intravascular brachytherapy&#xD;
&#xD;
        CE7. Subject has a known allergy to contrast (that cannot be adequately pre-medicated)&#xD;
        and/or the trial stent system or protocol-required concomitant medications (e.g., platinum,&#xD;
        platinum-chromium alloy, stainless steel, everolimus or structurally related compounds,&#xD;
        polymer or individual components, Clopidogrel , or aspirin)&#xD;
&#xD;
        CE8. Subject has one of the following (as assessed prior to the index procedure):&#xD;
&#xD;
          -  Other serious medical illness (e.g., cancer, congestive heart failure) with estimated&#xD;
             life expectancy of less than 12 months&#xD;
&#xD;
          -  Current problems with substance abuse (e.g., alcohol, cocaine, heroin, etc.)&#xD;
&#xD;
          -  Planned procedure that may cause non-compliance with the protocol or confound data&#xD;
             interpretation&#xD;
&#xD;
        CE9. Subject is receiving chronic (≥72 hours) anticoagulation therapy (i.e., heparin,&#xD;
        coumadin) for indications other than acute coronary syndrome&#xD;
&#xD;
        CE10. Subject with out of range complete blood count (CBC) values that are determined by&#xD;
        the study physician to be clinically significant.&#xD;
&#xD;
        CE11. Subject has documented or suspected liver disease, including laboratory evidence of&#xD;
        hepatitis&#xD;
&#xD;
        CE12. Subject is on dialysis or has baseline serum creatinine level &gt;2.0 mg/dL (177µmol/L)&#xD;
&#xD;
        CE13. Subject has a history of bleeding diathesis or coagulopathy or will refuse blood&#xD;
        transfusions&#xD;
&#xD;
        CE14. Subject has had a history of cerebrovascular accident (CVA) or transient ischemic&#xD;
        attack (TIA) within the past 6 months&#xD;
&#xD;
        CE15. Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding&#xD;
&#xD;
        CE16. Subject has signs or symptoms of active heart failure (i.e., NYHA class IV) at the&#xD;
        time of the index procedure&#xD;
&#xD;
        CE17. Subject is participating in another investigational drug or device clinical trial&#xD;
        that has not reached its primary endpoint&#xD;
&#xD;
        CE18. Subject intends to participate in another investigational drug or device clinical&#xD;
        trial within 12 months after the index procedure&#xD;
&#xD;
        CE19. 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;
        CE20. 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;
        CE21.Target vessel has been treated with any type of PCI (e.g., balloon angioplasty, stent,&#xD;
        cutting balloon, atherectomy) within 12 months prior to the index procedure&#xD;
&#xD;
          -  Angiographic Exclusion (AE) Criteria (visual estimate)&#xD;
&#xD;
        AE1. Planned treatment of more than 3 lesions.&#xD;
&#xD;
        AE2. Planned treatment of lesions in more than 2 major epicardial vessels&#xD;
&#xD;
        AE3. Planned treatment of a single lesion with more than 1 stent&#xD;
&#xD;
        AE4. Subject has 2 target lesions in the same vessel that are separated by less than 20 mm&#xD;
        (by visual estimate)&#xD;
&#xD;
        AE5. Target lesion(s) is located in the left main&#xD;
&#xD;
        AE6. 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;
        AE7. Target lesion(s) is located within a saphenous vein graft or an arterial graft&#xD;
&#xD;
        AE8. Target lesion(s) will be accessed via a saphenous vein graft or arterial graft&#xD;
&#xD;
        AE9. Target lesion(s) with a TIMI flow 0 (total occlusion) or TIMI flow 1 prior to guide&#xD;
        wire crossing&#xD;
&#xD;
        AE10. 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;
        AE11. Target lesion(s) is restenotic from a previous stent implantation or study stent&#xD;
        would overlap with a previous stent&#xD;
&#xD;
        AE12. Subject has unprotected left main coronary artery disease (&gt;50% diameter stenosis)&#xD;
&#xD;
        AE13. 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;
        AE14. Thrombus, or possible thrombus, present in the target vessel (by visual estimate)&#xD;
&#xD;
        AE15. Excessive tortuosity proximal to or within the lesion&#xD;
&#xD;
        AE16. Excessive angulation proximal to or within the lesion&#xD;
&#xD;
        AE17. Target lesion and/or the target vessel proximal to the target lesion is moderately to&#xD;
        severely calcified by visual estimate&#xD;
&#xD;
        AE18. Involves a side branch ≥2.0 mm in diameter by visual estimate or a side branch &lt;2.0&#xD;
        mm in diameter by visual estimate which requires treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jian'an Wang, Doctor</last_name>
    <role>Principal Investigator</role>
    <affiliation>2nd affiliated hospital of Zhejiang University College of Medicine</affiliation>
  </overall_official>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>August 20, 2014</study_first_submitted>
  <study_first_submitted_qc>September 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2014</study_first_posted>
  <results_first_submitted>August 31, 2020</results_first_submitted>
  <results_first_submitted_qc>February 23, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">May 12, 2022</results_first_posted>
  <last_update_submitted>February 23, 2022</last_update_submitted>
  <last_update_submitted_qc>February 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 12, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Coronary Artery Disease</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Atherosclerosis</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>Total Started: 101</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>PROMUS POREMIER Stent</title>
          <description>Single-arm treatment group receiving interventional PROMUS PRIMIER study stent&#xD;
Percutaneous coronary intervention PROMUS PREMIER: PROMUS PREMIER</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="101"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="98"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="3"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>PROMUS POREMIER Stent</title>
          <description>Single-arm treatment group receiving interventional PROMUS PRIMIER study stent&#xD;
Percutaneous coronary intervention PROMUS PREMIER: PROMUS PREMIER</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="101"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Year</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="61.47" spread="9.27"/>
                  </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="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="77"/>
                  </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 rate, 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>PROMUS POREMIER Stent</title>
            <description>Single-arm treatment group receiving interventional PROMUS PRIMIER study stent&#xD;
Percutaneous coronary intervention PROMUS PREMIER: PROMUS PREMIER</description>
          </group>
        </group_list>
        <measure>
          <title>Technical Success Rate</title>
          <description>Technical success rate, 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 participants</units>
          <param>Number</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</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="99.1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Target Lesion Revascularization (TLR) Rate</title>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Target Lesion Failure (TLF) Rate</title>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Target Vessel Revascularization (TVR) Rate</title>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6month and 12months</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Target Vessel Failure (TVF) Rate</title>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Myocardial Infarction (MI, Q-wave and Non-Q-wave) Rate</title>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cardiac Death Rate</title>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Non-cardiac Death Rate</title>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>All Death Rate</title>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Cardiac Death or MI Rate</title>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>All Death or MI Rate</title>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>All Death/MI/TVR Rate</title>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Stent Thrombosis Rate (by Academic Research Consortium [ARC] Definitions)</title>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Clinical Procedural Success Rate</title>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>In-stent and In-segment Percent Diameter Stenosis (%DS)</title>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>In-stent and In-segment Minimum Lumen Diameter (MLD)</title>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Acute Gain</title>
        <description>as measured by angiographic core lab, change from baseline for target lesions</description>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Longitudinal Stent Deformation (LSD) Rate</title>
        <time_frame>Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>PROMUS POREMIER Stent</title>
          <description>Single-arm treatment group receiving interventional PROMUS PRIMIER study stent&#xD;
Percutaneous coronary intervention PROMUS PREMIER: PROMUS PREMIER</description>
        </group>
      </group_list>
      <serious_events>
        <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="0" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="8" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="4" subjects_affected="3" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Atrial fibrillation</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Intracardiac thrombus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Ventricular extrasystoles</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </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="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Metabolism and nutrition disorders</title>
            <event_list>
              <event>
                <sub_title>Diabetes mellitus</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Subarachnoid haemorrhage</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <default_assessment>Non-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="13" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Cardiac disorders</title>
            <event_list>
              <event>
                <sub_title>Angina pectoris</sub_title>
                <counts group_id="E1" events="9" subjects_affected="9" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Angina unstable</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
              <event>
                <sub_title>Coronary artery dissection</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Gingival bleeding</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Investigations</title>
            <event_list>
              <event>
                <sub_title>Blood creatine phosphokinase increased</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="101"/>
              </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>There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr. Wang Jian'an</name_or_title>
      <organization>Second Affiliated Hospital of Zhejiang University</organization>
      <phone>010-85216440</phone>
      <email>Yuwei.Zhang@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/NCT02230254
org study id: S2323
nct id: NCT02230254
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
PE PREMIER China: A Prospective, Multicenter Trial to Assess the Promus PREMIERTM
      Everolimus-Eluting Platinum Chromium Coronary Stent System for the Treatment of
      Atherosclerotic Lesion(s)
To evaluate clinical and peri-procedural angiographic outcomes for the Promus PREMIERTM
      Everolimus-Eluting Platinum Chromium Coronary Stent System in the treatment of subjects with
      atherosclerotic lesion(s) ≤34 mm in length (by visual estimate) in native coronary arteries
      ≥2.25 mm to ≤4.0 mm in diameter (by visual estimate)
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 rate, 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, at 30 days, 6months and 12months
measure: Target Lesion Failure (TLF) Rate
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
measure: Target Vessel Revascularization (TVR) Rate
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6month and 12months
measure: Target Vessel Failure (TVF) Rate
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
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, at 30 days, 6months and 12months
measure: Cardiac Death Rate
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
measure: Non-cardiac Death Rate
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
measure: All Death Rate
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
measure: Cardiac Death or MI Rate
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
measure: All Death or MI Rate
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
measure: All Death/MI/TVR Rate
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
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, at 30 days, 6months and 12months
measure: Clinical Procedural Success Rate
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
measure: In-stent and In-segment Percent Diameter Stenosis (%DS)
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
measure: In-stent and In-segment Minimum Lumen Diameter (MLD)
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
measure: Acute Gain
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
description: as measured by angiographic core lab, change from baseline for target lesions
measure: Longitudinal Stent Deformation (LSD) Rate
time frame: Participants will be followed for the duration of hospital stay, an expected average of 1 day, at 30 days, 6months and 12months
arm group label: PROMUS POREMIER stent
arm group type: Experimental
description: Single-arm treatment group receiving interventional PROMUS PRIMIER study stent
intervention type: Device
intervention name: Percutaneous coronary intervention PROMUS PREMIER
description: PROMUS PREMIER
arm group label: PROMUS POREMIER stent
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Jian'an Wang, Doctor
role: Principal Investigator
affiliation: 2nd affiliated hospital of Zhejiang University College of Medicine
responsible party type: Sponsor
mesh term: Atherosclerosis
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 