<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/NCT02256449</url>
  </required_header>
  <id_info>
    <org_study_id>COR-BVS-2013-01</org_study_id>
    <nct_id>NCT02256449</nct_id>
  </id_info>
  <brief_title>REPARA Study: REgistry of PAtients With bioResorbable Device in Daily Clinical prActice</brief_title>
  <acronym>REPARA</acronym>
  <official_title>Registry of Patients With Bioresorbable Device in Daily Clinical Practice. REPARA Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sección Hemodinamica y Cardiologia Intervencionista</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sección Hemodinamica y Cardiologia Intervencionista</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      A multicentre, observational, prospective device registry, with no control group, designed to&#xD;
      evaluate the efficacy and safety of the bioresorbable coronary device, used according to the&#xD;
      indications of use, in daily clinical practice in a consecutive number of patients undergoing&#xD;
      PCI in de novo coronary artery lesions. A total of 1,500 patients are planned to be included&#xD;
      in the registry.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The patients will be included consecutively at each site for one year. They will be&#xD;
      individuals from both sexes, requiring endovascular intervention and meeting the authorised&#xD;
      criteria for the indications of use of the device to be used and where dual anti-platelet&#xD;
      therapy (DAPT) with aspirin and thienopyridines is considered.&#xD;
&#xD;
      STUDY OBJECTIVES To evaluate the MACE rate after implantation of the bioresorbable coronary&#xD;
      device in patients with de novo coronary artery lesions, where a follow-up of 12 months will&#xD;
      be performed.&#xD;
&#xD;
      Primary objective:&#xD;
&#xD;
      MACE rate at 12 months of follow-up:&#xD;
&#xD;
      Cardiac death Myocardial infarction TLR driven by ischaemia of the lesion treated or of the&#xD;
      region of 5 mm proximally or distally to the site of implantation of the device (ID-TLR).&#xD;
&#xD;
      Secondary objectives:&#xD;
&#xD;
        -  Angina&#xD;
&#xD;
        -  Death due to any cause.&#xD;
&#xD;
        -  Myocardial infarction of any type (MI: QMI, NQMI, TV, NTV)&#xD;
&#xD;
        -  All TLR driven or not by ischaemia&#xD;
&#xD;
        -  All TVR driven or not by ischaemia.&#xD;
&#xD;
        -  All coronary revascularisations performed (PCI vs CABG)&#xD;
&#xD;
        -  Device thrombosis (acute, sub-acute, late) and evidence (definitive, probable,&#xD;
           possible).&#xD;
&#xD;
        -  Immediate success of the device.&#xD;
&#xD;
        -  Immediate success of the procedure.&#xD;
&#xD;
        -  Rate of patients with DAPT at &lt; 1 month, 1-3 months, 3-6 months, and 6-12 months and&#xD;
           relationship with the occurrence of events&#xD;
&#xD;
        -  Composite endpoints:&#xD;
&#xD;
      Cardiac death, TV-MI and ID-TLR: (Target Lesion Failure (TLF)) Cardiac death, any myocardial&#xD;
      infarction (MI) and ID-TVR: (Target Vessel Failure (TVF))&#xD;
&#xD;
        -  Rate of overlapping devices: characteristics and relationship with occurrence of events&#xD;
&#xD;
        -  Collection of imaging data of the cases where, according to the judgement of the&#xD;
           investigator, intravascular imaging tests have been performed (IVUS, OCT).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>January 2014</start_date>
  <completion_date type="Anticipated">October 2016</completion_date>
  <primary_completion_date type="Actual">September 2015</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>1 Year</target_duration>
  <primary_outcome>
    <measure>MACE rate (major adverse cardiac events) at 12 months of follow-up: Cardiac death; Myocardial infarction; Target lesion revascularisation (TLR) ischemia-driven: Cardiac Death/All MI/ID-TLR</measure>
    <time_frame>Clinical follow-up at 12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immediate success of the device/procedure</measure>
    <time_frame>1 day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac death</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial infarction</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scaffold/Stent Thrombosis: Timing and Evidence</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target lesion/vessel revascularization (TLR/TVR)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angina Events</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of patients with DAPT at 12 months</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of overlapping devices and characteristics</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2440</enrollment>
  <condition>Coronary Artery Lesions With Implantation of Coronary Device</condition>
  <arm_group>
    <arm_group_label>BVS patients</arm_group_label>
    <description>Use of bioresorbable coronary device, according to the indications of use, in daily clinical practice, in patients undergoing PCI in de novo coronary artery lesions.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with native coronary artery de novo lesions with indication for revascularization&#xD;
        with a coronary device&#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 at the time of signing the Informed Consent&#xD;
             Form&#xD;
&#xD;
          -  Patient is to be treated for de novo coronary lesions in a native coronary artery and&#xD;
             amenable to receive a bioresorbable device&#xD;
&#xD;
          -  The length of the treated lesion should be inferior to the nominal length of the&#xD;
             device (12 mm, 18 mm, 28 mm) with a reference vessel diameter &gt; 2 mm y &lt; 3,8 mm.&#xD;
&#xD;
          -  The patient will not have any relative contraindication for double antiplatelet&#xD;
             therapy, with aspirin indefinitely and with a thienopyridine for at least 6 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Cardiogenic shock&#xD;
&#xD;
          -  Left main disease&#xD;
&#xD;
          -  Aortocoronary graft&#xD;
&#xD;
          -  Intrastent restenosis&#xD;
&#xD;
          -  Potentially child-bearing women with no contraceptive methods&#xD;
&#xD;
          -  Pregnant or breast-feeding women&#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>Felipe Hernandez, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seccion Hemodinamica y Cardiologia Intervencionista</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hospital 12 de Octubre</name>
      <address>
        <city>Madrid</city>
        <zip>28041</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>July 2016</verification_date>
  <study_first_submitted>September 23, 2014</study_first_submitted>
  <study_first_submitted_qc>September 30, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 3, 2014</study_first_posted>
  <last_update_submitted>July 15, 2016</last_update_submitted>
  <last_update_submitted_qc>July 15, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 18, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Coronary artery disease; angioplasty; bioresorbable device</keyword>
  <!-- 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/NCT02256449
org study id: COR-BVS-2013-01
nct id: NCT02256449
lead sponsor: 
has dmc: Yes
A multicentre, observational, prospective device registry, with no control group, designed to
      evaluate the efficacy and safety of the bioresorbable coronary device, used according to the
      indications of use, in daily clinical practice in a consecutive number of patients undergoing
      PCI in de novo coronary artery lesions. A total of 1,500 patients are planned to be included
      in the registry.
The patients will be included consecutively at each site for one year. They will be
      individuals from both sexes, requiring endovascular intervention and meeting the authorised
      criteria for the indications of use of the device to be used and where dual anti-platelet
      therapy (DAPT) with aspirin and thienopyridines is considered.

      STUDY OBJECTIVES To evaluate the MACE rate after implantation of the bioresorbable coronary
      device in patients with de novo coronary artery lesions, where a follow-up of 12 months will
      be performed.

      Primary objective:

      MACE rate at 12 months of follow-up:

      Cardiac death Myocardial infarction TLR driven by ischaemia of the lesion treated or of the
      region of 5 mm proximally or distally to the site of implantation of the device (ID-TLR).

      Secondary objectives:

        -  Angina

        -  Death due to any cause.

        -  Myocardial infarction of any type (MI: QMI, NQMI, TV, NTV)

        -  All TLR driven or not by ischaemia

        -  All TVR driven or not by ischaemia.

        -  All coronary revascularisations performed (PCI vs CABG)

        -  Device thrombosis (acute, sub-acute, late) and evidence (definitive, probable,
           possible).

        -  Immediate success of the device.

        -  Immediate success of the procedure.

        -  Rate of patients with DAPT at < 1 month, 1-3 months, 3-6 months, and 6-12 months and
           relationship with the occurrence of events

        -  Composite endpoints:

      Cardiac death, TV-MI and ID-TLR: (Target Lesion Failure (TLF)) Cardiac death, any myocardial
      infarction (MI) and ID-TVR: (Target Vessel Failure (TVF))

        -  Rate of overlapping devices: characteristics and relationship with occurrence of events

        -  Collection of imaging data of the cases where, according to the judgement of the
           investigator, intravascular imaging tests have been performed (IVUS, OCT).
observational model: Cohort
time perspective: Prospective
measure: MACE rate (major adverse cardiac events) at 12 months of follow-up: Cardiac death; Myocardial infarction; Target lesion revascularisation (TLR) ischemia-driven: Cardiac Death/All MI/ID-TLR
time frame: Clinical follow-up at 12 months
measure: Immediate success of the device/procedure
time frame: 1 day
measure: Cardiac death
time frame: 12 months
measure: Myocardial infarction
time frame: 12 months
measure: Scaffold/Stent Thrombosis: Timing and Evidence
time frame: 12 months
measure: Target lesion/vessel revascularization (TLR/TVR)
time frame: 12 months
measure: Angina Events
time frame: 12 months
measure: Rate of patients with DAPT at 12 months
time frame: 12 months
measure: Rate of overlapping devices and characteristics
time frame: 12 months
arm group label: BVS patients
description: Use of bioresorbable coronary device, according to the indications of use, in daily clinical practice, in patients undergoing PCI in de novo coronary artery lesions.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Felipe Hernandez, MD
role: Principal Investigator
affiliation: Seccion Hemodinamica y Cardiologia Intervencionista
facility: 
country: Spain
responsible party type: Sponsor