<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/NCT03273023</url>
  </required_header>
  <id_info>
    <org_study_id>S2384</org_study_id>
    <nct_id>NCT03273023</nct_id>
  </id_info>
  <brief_title>PROMUS PREMIER™ China Post-Approval Study</brief_title>
  <official_title>Post-Approval Study of the PROMUS PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System in China</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      To compile real-world clinical outcome data for the Promus PREMIERTM Everolimus-Eluting&#xD;
      Platinum Chromium Coronary Stent System (Promus PREMIERTM Stent System) in routine clinical&#xD;
      practice in China.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Each site will be allowed to enroll up to a maximum of 300 subjects. The scheduled follow up&#xD;
      will occur at 30 days, 6 months, 12 months and then annually through 5 years post stent&#xD;
      implant, for all enrolled subjects. Follow-up will be conducted via telephone contact or&#xD;
      clinic visit&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 11, 2018</start_date>
  <completion_date type="Anticipated">June 30, 2024</completion_date>
  <primary_completion_date type="Actual">December 28, 2020</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>5 Years</target_duration>
  <primary_outcome>
    <measure>12-month Primary Endpoint: Major Adverse Cardiac Event (MACE) rate, defined as cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR)</measure>
    <time_frame>12-month follow up</time_frame>
    <description>The primary endpoint is the 12-month major adverse cardiac event (MACE) rate, defined as cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR)</description>
  </primary_outcome>
  <enrollment type="Actual">2059</enrollment>
  <condition>Coronary Artery Disease</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System</intervention_name>
    <description>Promus PREMIERTM Stent System</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All subjects who are candidates for coronary artery stenting, signed the informed consent&#xD;
        form and eligible to receive a Promus PREMIERTM Stent System will be evaluated for&#xD;
        enrollment in this study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject must be at least 18 years of age&#xD;
&#xD;
          -  Subject understands and provides written informed consent&#xD;
&#xD;
          -  Subject who is clinically indicated and will have an attempt of at least one Promus&#xD;
             PREMIERTM Stent OR Subject who is clinically indicated and was implanted with at least&#xD;
             one Promus PREMIERTM Stent&#xD;
&#xD;
          -  Subject is willing to comply with all protocol-required follow-up evaluation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria are not required in the PE PREMIERTM China Post-Approval Study&#xD;
             which is an &quot;all comers&quot; study.&#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>Zhiyu Zeng</last_name>
    <role>Study Chair</role>
    <affiliation>Boston Scientific Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>QiLu Hospital of ShanDong University</name>
      <address>
        <city>Qingdao</city>
        <state>Shandong</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>September 4, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>August 23, 2023</last_update_submitted>
  <last_update_submitted_qc>August 23, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 25, 2023</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>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chromium</mesh_term>
    <mesh_term>Everolimus</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT03273023
org study id: S2384
nct id: NCT03273023
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
To compile real-world clinical outcome data for the Promus PREMIERTM Everolimus-Eluting
      Platinum Chromium Coronary Stent System (Promus PREMIERTM Stent System) in routine clinical
      practice in China.
Each site will be allowed to enroll up to a maximum of 300 subjects. The scheduled follow up
      will occur at 30 days, 6 months, 12 months and then annually through 5 years post stent
      implant, for all enrolled subjects. Follow-up will be conducted via telephone contact or
      clinic visit
observational model: Case-Only
time perspective: Prospective
measure: 12-month Primary Endpoint: Major Adverse Cardiac Event (MACE) rate, defined as cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR)
time frame: 12-month follow up
description: The primary endpoint is the 12-month major adverse cardiac event (MACE) rate, defined as cardiac death, myocardial infarction (MI) and target vessel revascularization (TVR)
intervention type: Device
intervention name: Promus PREMIERTM Everolimus-Eluting Platinum Chromium Coronary Stent System
description: Promus PREMIERTM Stent System
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zhiyu Zeng
role: Study Chair
affiliation: Boston Scientific Corporation
facility: 
country: China
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Chromium
mesh term: Everolimus
sharing ipd: Undecided