<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/NCT03809715</url>
  </required_header>
  <id_info>
    <org_study_id>AAG-O-H-1803</org_study_id>
    <nct_id>NCT03809715</nct_id>
  </id_info>
  <brief_title>Coroflex ISAR NEO &quot;All Comers&quot; Post Market Clinical Follow-up (PMCF)</brief_title>
  <official_title>Post-marketing Clinical Follow-up Study With Coroflex® ISAR Neo</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>B. Braun Melsungen AG</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>B. Braun Melsungen AG</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>
      The aim of the study is to assess the safety and efficacy of the device to treat coronary de&#xD;
      novo and restenotic lesions.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Post-authorisation / after Conformité Européene (CE) marking Coroflex® ISAR NEO is a drug&#xD;
      eluting stent system which is an improved version of the predecessor device Coroflex® ISAR&#xD;
      which was extensively studied in the ISAR 2000 Registry. The rationale of this observational,&#xD;
      post-market, single-armed study is to confirm the safety and efficacy of Coroflex® ISAR NEO,&#xD;
      also as part of the manufacturer's post-market surveillance obligations in particular for the&#xD;
      re-certification of the device.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 17, 2019</start_date>
  <completion_date type="Anticipated">June 2025</completion_date>
  <primary_completion_date type="Anticipated">March 2024</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 Revascularization (TLR) rate at 12 months</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Accumulated Major Adverse Cardiovascular Events (MACE) rate at 12 months (including intra-hospital events)</measure>
    <time_frame>12 months</time_frame>
    <description>MACE consists of all events TLR (Re-Percutaneous Coronary Intervention (Re-PCI), Coronary Artery Bypass Grafting (CABG)), Myocardial Infarction (MI), cardiac death (inhospital) and all-cause death up to 12 months. MI is defined as a new event documented with elevated cardiac enzymes during the follow-up. Elevated enzyme levels during the hospital stay are not considered as a new event.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Accumulated Target Vessel Failure Rate at 12 months (including intra-hospital events)</measure>
    <time_frame>12 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent thrombosis rates accumulated up to 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>Stent thrombosis is defined as thrombosis in the treated coronary lesion only. No venous thrombotic events are relevant for this end point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of bleeding complications accumulated up to 12 months</measure>
    <time_frame>12 months</time_frame>
    <description>To assess the bleeding complications the Bleeding Academic Research Consortium (BARC) scale will be used.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Technical/procedural success rate</measure>
    <time_frame>immediately after procedure</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">3520</enrollment>
  <condition>Coronary Artery Disease</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Coroflex® ISAR NEO coronary stent system</intervention_name>
    <description>treatment of coronary artery disease with Coroflex® ISAR NEO of &quot;real world&quot; de-novo and restenotic lesions in native coronary arteries and coronary bypass grafts</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The investigator of each study site has the responsibility of screening all potential&#xD;
        patients and selecting those who fulfil the inclusion criteria of this study protocol.&#xD;
        Therefore, at each site a study with similar inclusion criteria cannot be conducted while&#xD;
        the recruitment of this study is in progress.&#xD;
&#xD;
        Screening will be performed during the physical examination to verify the &quot;patient related&#xD;
        enrolment criteria&quot;. The second part of the screening procedure will be completed during&#xD;
        the diagnostic angiography to verify that the target lesion fulfils all &quot;lesion related&#xD;
        enrolment criteria&quot;.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Coroflex® ISAR NEO is intended to be used for&#xD;
&#xD;
          -  All common significant coronary lesions&#xD;
&#xD;
          -  Target lesion length &gt;34mm need to be covered with at least 2 stents&#xD;
&#xD;
          -  Patients eligible for this study must be at least 18 years of age.&#xD;
&#xD;
          -  The patient must fulfill the standard recommendations for Percutaneous Coronary&#xD;
             Intervention (PCI) based on the last European Society of Cardiology (ESC)&#xD;
             recommendations within his/ her regular treatment or that the use of the product has&#xD;
             already been decided within the regular planning of the patient's treatment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intolerance to sirolimus and/or probucol&#xD;
&#xD;
          -  Allergy to components of the coating&#xD;
&#xD;
          -  Pregnancy and lactation&#xD;
&#xD;
          -  Complete occlusion of the treatment vessel because of an unsuccessfully re-canalized&#xD;
&#xD;
          -  Cardiogenic shock&#xD;
&#xD;
          -  Risk of an intraluminal thrombus&#xD;
&#xD;
          -  Hemorrhagic diathesis or another disorder such as gastro-intestinal ulceration or&#xD;
             cerebral circulatory disorders which restrict the use of platelet aggregation&#xD;
             inhibitor therapy and anti-coagulation therapy&#xD;
&#xD;
          -  Surgery shortly after myocardial infarction with indications of thrombus or poor&#xD;
             coronary flow behavior&#xD;
&#xD;
          -  Severe allergy to contrast media&#xD;
&#xD;
          -  Lesions which are untreatable with PCI or other interventional techniques&#xD;
&#xD;
          -  Patients with an ejection fraction of &lt; 30 %&#xD;
&#xD;
          -  Vascular reference diameter &lt; 2.00 mm&#xD;
&#xD;
          -  Treatment of the left stem (first section of the left coronary artery)&#xD;
&#xD;
          -  Indication for a bypass surgery&#xD;
&#xD;
          -  Contraindication for whichever accompanying medication is necessary&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Rene Koning, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Clinique St. Hilaire</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Clinique St. Hilaire</name>
      <address>
        <city>Rouen</city>
        <zip>76000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 17, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <last_update_submitted>September 11, 2023</last_update_submitted>
  <last_update_submitted_qc>September 11, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 13, 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>
  <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/NCT03809715
org study id: AAG-O-H-1803
nct id: NCT03809715
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of the study is to assess the safety and efficacy of the device to treat coronary de
      novo and restenotic lesions.
Post-authorisation / after Conformité Européene (CE) marking Coroflex® ISAR NEO is a drug
      eluting stent system which is an improved version of the predecessor device Coroflex® ISAR
      which was extensively studied in the ISAR 2000 Registry. The rationale of this observational,
      post-market, single-armed study is to confirm the safety and efficacy of Coroflex® ISAR NEO,
      also as part of the manufacturer's post-market surveillance obligations in particular for the
      re-certification of the device.
observational model: Cohort
time perspective: Prospective
measure: Target Lesion Revascularization (TLR) rate at 12 months
time frame: 12 months
measure: Accumulated Major Adverse Cardiovascular Events (MACE) rate at 12 months (including intra-hospital events)
time frame: 12 months
description: MACE consists of all events TLR (Re-Percutaneous Coronary Intervention (Re-PCI), Coronary Artery Bypass Grafting (CABG)), Myocardial Infarction (MI), cardiac death (inhospital) and all-cause death up to 12 months. MI is defined as a new event documented with elevated cardiac enzymes during the follow-up. Elevated enzyme levels during the hospital stay are not considered as a new event.
measure: Accumulated Target Vessel Failure Rate at 12 months (including intra-hospital events)
time frame: 12 months
measure: Stent thrombosis rates accumulated up to 12 months
time frame: 12 months
description: Stent thrombosis is defined as thrombosis in the treated coronary lesion only. No venous thrombotic events are relevant for this end point.
measure: Rate of bleeding complications accumulated up to 12 months
time frame: 12 months
description: To assess the bleeding complications the Bleeding Academic Research Consortium (BARC) scale will be used.
measure: Technical/procedural success rate
time frame: immediately after procedure
intervention type: Device
intervention name: Coroflex® ISAR NEO coronary stent system
description: treatment of coronary artery disease with Coroflex® ISAR NEO of "real world" de-novo and restenotic lesions in native coronary arteries and coronary bypass grafts
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Rene Koning, MD
role: Principal Investigator
affiliation: Clinique St. Hilaire
facility: 
country: France
responsible party type: Sponsor
mesh term: Coronary Artery Disease
sharing ipd: No