<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/NCT01677585</url>
  </required_header>
  <id_info>
    <org_study_id>S2288</org_study_id>
    <nct_id>NCT01677585</nct_id>
  </id_info>
  <brief_title>Post-Approval Study of PROMUS Element™ in China</brief_title>
  <acronym>PEChina</acronym>
  <official_title>PROMUS Element™ China Post-Approval Study</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>
      The purpose of this study is to compile real-world clinical outcomes data for the PROMUS&#xD;
      Element™ and PROMUS Element™ Plus Everolimus-Eluting Coronary Stent System (PROMUS Element&#xD;
      and PROMUS Element Plus Stent System) in routine clinical practice in China.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Everolimus-eluting stents have been studied extensively in ongoing clinical studies. The&#xD;
      safety and effectiveness of the everolimus drug and polymer combination have been studied&#xD;
      extensively in the SPIRIT Clinical Trial Program. The PROMUS Element stent is currently being&#xD;
      studied in the PLATINUM Clinical Trial Program. The PROMUS Element stent is also being&#xD;
      evaluated in PROMUS Element Plus US post-approval studies and the ongoing Platinum China&#xD;
      study. This study is designed to provide post-market surveillance information on the PROMUS&#xD;
      Element™ and PROMUS Element™ Everolimus-Eluting Coronary Stent System (PROMUS Element and&#xD;
      PROMUS Element Plus Stent System) after it has been approved by SFDA (State of Food and Drug&#xD;
      Administration) in China. The study will evaluate clinical outcomes for subjects receiving&#xD;
      the PROMUS Element and PROMUS Element plus stents over 5 years in a real world setting&#xD;
      according to post approval requirements from SFDA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2012</start_date>
  <completion_date type="Actual">December 2019</completion_date>
  <primary_completion_date type="Actual">December 2015</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Target Lesion Failure (TLF) rate</measure>
    <time_frame>12-month</time_frame>
    <description>The primary endpoint is the 12-month target lesion failure (TLF) rate, defined as any ischemia-driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death.</description>
  </primary_outcome>
  <enrollment type="Actual">2016</enrollment>
  <condition>Coronary Artery Disease</condition>
  <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 Element stent will be evaluated for enrollment in&#xD;
        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;
             Element stent OR Subject who is clinically indicated and was implanted with at least&#xD;
             one PROMUS Element stent&#xD;
&#xD;
          -  Subject is willing to comply with all protocol-required follow-up evaluation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria is not required in the PROMUS Element 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>Jian'an Wang, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Second Affliated Hosptial Zhejiang University College of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Second Affliated Hosptial Zhejiang University College of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>August 30, 2012</study_first_submitted>
  <study_first_submitted_qc>August 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 3, 2012</study_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">February 24, 2022</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>
  <patient_data>
    <sharing_ipd>No</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/NCT01677585
org study id: S2288
nct id: NCT01677585
lead sponsor: 
has dmc: No
The purpose of this study is to compile real-world clinical outcomes data for the PROMUS
      Element™ and PROMUS Element™ Plus Everolimus-Eluting Coronary Stent System (PROMUS Element
      and PROMUS Element Plus Stent System) in routine clinical practice in China.
Everolimus-eluting stents have been studied extensively in ongoing clinical studies. The
      safety and effectiveness of the everolimus drug and polymer combination have been studied
      extensively in the SPIRIT Clinical Trial Program. The PROMUS Element stent is currently being
      studied in the PLATINUM Clinical Trial Program. The PROMUS Element stent is also being
      evaluated in PROMUS Element Plus US post-approval studies and the ongoing Platinum China
      study. This study is designed to provide post-market surveillance information on the PROMUS
      Element™ and PROMUS Element™ Everolimus-Eluting Coronary Stent System (PROMUS Element and
      PROMUS Element Plus Stent System) after it has been approved by SFDA (State of Food and Drug
      Administration) in China. The study will evaluate clinical outcomes for subjects receiving
      the PROMUS Element and PROMUS Element plus stents over 5 years in a real world setting
      according to post approval requirements from SFDA.
observational model: Cohort
time perspective: Prospective
measure: Target Lesion Failure (TLF) rate
time frame: 12-month
description: The primary endpoint is the 12-month target lesion failure (TLF) rate, defined as any ischemia-driven revascularization of the target lesion (TLR), myocardial infarction (MI, Q-wave and non-Q-wave) related to the target vessel, or cardiac death.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jian'an Wang, Professor
role: Principal Investigator
affiliation: Second Affliated Hosptial Zhejiang University College of Medicine
facility: 
country: China
responsible party type: Sponsor
mesh term: Coronary Artery Disease
sharing ipd: No