<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/NCT02216058</url>
  </required_header>
  <id_info>
    <org_study_id>WR-CT-001</org_study_id>
    <nct_id>NCT02216058</nct_id>
  </id_info>
  <brief_title>Safety and Efficacy Study of NOYA Sirolimus-Eluting Stent to Treat Coronary Artery Disease</brief_title>
  <official_title>A Prospective, Multicenter Trial of NOYA Sirolimus-Eluting Stent With Biodegradable Coating in Patients With Coronary Artery Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medfavour (Beijing) Medical Co., Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medfavour (Beijing) Medical Co., Ltd</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A prospective, multicenter study is preformed to evaluate the safety and efficacy of NOYA&#xD;
      CoCr biodegradable coating sirolimus-eluting stents in treating coronary artery lesions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A prospective, multicenter study is preformed to evaluate the safety and efficacy of NOYA&#xD;
      CoCr biodegradable coating sirolimus-eluting stents in treating coronary artery lesions.&#xD;
      Appropriate patients judged by inclusion and exclusion standards will be preformed stent&#xD;
      implantation, and after that all patients will be clinically followed up at 30, 180, 365&#xD;
      days,2 years,3 years,4 years and 5 years. Target Lesion Failure (TLF) found in following-up&#xD;
      period as key indicators to evaluate the safety of stents. The arrangement, conclusion and&#xD;
      statistical analysis of trial data including clinography and angiography will be fulfilled by&#xD;
      independent Data Management Center(DMC) and radiography core laboratory.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2013</start_date>
  <completion_date type="Anticipated">June 2020</completion_date>
  <primary_completion_date type="Anticipated">June 2017</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>TLF(Target Lesion Failure)</measure>
    <time_frame>24 months</time_frame>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">2000</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>NOYA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stent System</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stent System</intervention_name>
    <arm_group_label>NOYA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient must be ≥18 of age; male or non-pregnant female.&#xD;
&#xD;
          -  Diagnosis of coronary artery disease.&#xD;
&#xD;
          -  At least one target lesion with a diameter stenosis ≥70% (visual estimate)&#xD;
&#xD;
          -  Acceptable candidate for CABG;&#xD;
&#xD;
          -  The patient or legally authorized representative has been informed of the nature of&#xD;
             the study, agrees to its provisions and has been provided written Notice of Informed&#xD;
             Consent, appropriate Ethics Committee(EC); and the patient is willing to comply with&#xD;
             specified follow-up evaluations.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient has congenital heart disease, severe valve dysfunction, bridge vascular&#xD;
             disease, severe heart failure (NYHA ≥ Ⅲ level), or left ventricular ejection fraction&#xD;
             ≤ 30%.&#xD;
&#xD;
          -  Patient has undergone previous stenting anywhere within the previous 1 year. Patient&#xD;
             has a preoperative renal dysfunction: serum creatinine&gt; 2.0mg/dl (176.82umol / L).&#xD;
&#xD;
          -  Patient has a history of bleeding diathesis or coagulopathy or patients in whom&#xD;
             anti-platelet and/or anticoagulant therapy is contraindicated or in which patient will&#xD;
             not be able to comply with dual antiplatelet therapy for at least 1 year;&#xD;
&#xD;
          -  Patient has a known hypersensitivity or contraindication to aspirin,&#xD;
             heparin/bivalirudin, clopidogrel/ticlopidine, Prasugrel, stainless steel alloy, cobalt&#xD;
             chromium, rapamycin, styrene-butylene-styrene or poly-lactic acid (PLA) polymer,&#xD;
             and/or contrast sensitivity that cannot be adequately premedicated;&#xD;
&#xD;
          -  Patient is allergic to contrast agent Sirolimus.&#xD;
&#xD;
          -  Patient has a limited life expectancy is less than 12 months.&#xD;
&#xD;
          -  Currently participating in another investigational drug or device study or patient in&#xD;
             inclusion in another investigational drug or device study during follow-up.&#xD;
&#xD;
          -  Patient has poor compliance with the judgment of the investigator and can not complete&#xD;
             the study as required.&#xD;
&#xD;
          -  Patient who had heart transplant.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yundai Chen, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chines PLA General Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Chinese PLA General Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100853</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yundai Chen, Dr.</last_name>
      <phone>010-55499209</phone>
      <email>cyundai@medmail.com.cn</email>
    </contact>
    <investigator>
      <last_name>Yundai Chen, Dr.</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 11, 2014</study_first_submitted>
  <study_first_submitted_qc>August 12, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 13, 2014</study_first_posted>
  <last_update_submitted>August 12, 2014</last_update_submitted>
  <last_update_submitted_qc>August 12, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 13, 2014</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>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sirolimus</mesh_term>
  </intervention_browse>
  <!-- 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/NCT02216058
org study id: WR-CT-001
nct id: NCT02216058
lead sponsor: 
has dmc: Yes
A prospective, multicenter study is preformed to evaluate the safety and efficacy of NOYA
      CoCr biodegradable coating sirolimus-eluting stents in treating coronary artery lesions.
A prospective, multicenter study is preformed to evaluate the safety and efficacy of NOYA
      CoCr biodegradable coating sirolimus-eluting stents in treating coronary artery lesions.
      Appropriate patients judged by inclusion and exclusion standards will be preformed stent
      implantation, and after that all patients will be clinically followed up at 30, 180, 365
      days,2 years,3 years,4 years and 5 years. Target Lesion Failure (TLF) found in following-up
      period as key indicators to evaluate the safety of stents. The arrangement, conclusion and
      statistical analysis of trial data including clinography and angiography will be fulfilled by
      independent Data Management Center(DMC) and radiography core laboratory.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: TLF(Target Lesion Failure)
time frame: 24 months
arm group label: NOYA
arm group type: Experimental
description: NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stent System
intervention type: Device
intervention name: NOYA CoCr Biodegradable Coating Sirolimus-Eluting Stent System
arm group label: NOYA
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Yundai Chen, Dr.
role: Principal Investigator
affiliation: Chines PLA General Hospital
facility: 
status: Recruiting
contact: 
investigator: 
country: China
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Ischemia
mesh term: Coronary Disease
mesh term: Sirolimus