<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/NCT03307213</url>
  </required_header>
  <id_info>
    <org_study_id>17EU02</org_study_id>
    <nct_id>NCT03307213</nct_id>
  </id_info>
  <brief_title>BioFreedom QCA Study in CAD Patients</brief_title>
  <acronym>BioFreedomQCA</acronym>
  <official_title>Evaluation of the Efficacy (QCA) and Safety of the BioFreedom™ Biolimus A9™ CoCr Stent in a Randomised Trial in Patients With CAD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biosensors Europe SA</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Biosensors Europe SA</source>
  <oversight_info>
    <has_dmc>Yes</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>
      This study aims to demonstrate that the BioFreedom™ Cobalt Chromium Drug Coated Stent is&#xD;
      non-inferior to the market authorized BioFreedom™ Stainless Steel Stent with respective to&#xD;
      efficacy and shows a similar safety profile.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The BioFreedom™ QCA trial is designed to evaluate the safety and efficacy of the BioFreedom™&#xD;
      CoCr DCS coronary stent system compared to the Biofreedom™ stainless steel DCS coronary stent&#xD;
      system, in a randomized controlled trial on an all-comers patient population.&#xD;
&#xD;
      The primary objective is to measure non-inferiority of the BioFreedom™ CoCr stent compared to&#xD;
      BioFreedom™ DCS as measured by the difference in angiographically measured late lumen loss at&#xD;
      9 months, and the main secondary endpoint is to assess safety as measured by MACE and ST. Two&#xD;
      hundred (200) patients will be randomized 1:1 to either stent, allowing for a direct&#xD;
      comparison, and will be followed-up to 2 years to measure for late MACE and ST events.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">June 19, 2018</start_date>
  <completion_date type="Anticipated">March 31, 2021</completion_date>
  <primary_completion_date type="Actual">September 30, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Patients will be randomised to one of the treatment arms to receive either the BioFreedom™ SS or the BioFreedom™ CoCr stent.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>In-stent late lumen loss (LLL) at 9 months</measure>
    <time_frame>9 months</time_frame>
    <description>In-stent late lumen loss (LLL) assessed by quantitative coronary angiography (QCA) at 9 months</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cardiac Death</measure>
    <time_frame>1, 9, 12 and 24 months</time_frame>
    <description>Cardiac Death</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial infarction</measure>
    <time_frame>1, 9, 12 and 24 months</time_frame>
    <description>Myocardial infarction</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>MACE</measure>
    <time_frame>1, 9, 12 and 24 months</time_frame>
    <description>MACE defined as cardiac death, myocardial infarction and clinically indicated</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">200</enrollment>
  <condition>Coronary Artery Disease</condition>
  <condition>Cardiac Death</condition>
  <condition>Myocardial Infarction</condition>
  <arm_group>
    <arm_group_label>BioFreedom™CoCr</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients with CAD will receive the BioFreedom™CoCr stent if randomised to this arm.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BioFreedom™ SS</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients with CAD will receive the BioFreedom™SS stent if randomised to this arm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BioFreedom™ CoCr Biolimus A9™ stent</intervention_name>
    <description>Stent implantation</description>
    <arm_group_label>BioFreedom™CoCr</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BioFreedom™ SS Biolimus A9™ stent</intervention_name>
    <description>Stent implantation</description>
    <arm_group_label>BioFreedom™ SS</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        &quot;Real world, all comer&quot; patients&#xD;
&#xD;
          1. Age ≥18 years;&#xD;
&#xD;
          2. Symptomatic coronary artery disease including patients with chronic stable angina,&#xD;
             unstable angina, silent ischemia, and acute coronary syndromes including non-ST&#xD;
             elevation myocardial infarction and ST-elevation myocardial infarction;&#xD;
&#xD;
          3. Presence of one or more coronary artery stenosis &gt;50% in a native coronary artery or a&#xD;
             saphenous bypass graft from 2.50 to 3.5 mm in diameter that can be covered with one or&#xD;
             multiple stents (angiographic inclusion);&#xD;
&#xD;
          4. No limitation on the number of treated lesions, and vessels, and lesion length&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Individual is pregnant, nursing or planning to be pregnant;&#xD;
&#xD;
          2. Known intolerance to aspirin, clopidogrel, heparin, stainless steel, cobalt chromium,&#xD;
             Biolimus A9™ or contrast material&#xD;
&#xD;
          3. Inability to provide informed consent;&#xD;
&#xD;
        Note: Not all exclusion criteria are listed.&#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>Manel Sabate, Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hospital Clinic of Barcelona</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Rigshospitalet, University of Copenhagen</name>
      <address>
        <city>Copenhagen</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Clinic de Barcelona</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
    <country>Spain</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>October 6, 2017</study_first_submitted>
  <study_first_submitted_qc>October 6, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>December 23, 2019</last_update_submitted>
  <last_update_submitted_qc>December 23, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 24, 2019</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 Infarction</mesh_term>
    <mesh_term>Infarction</mesh_term>
    <mesh_term>Death</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sirolimus</mesh_term>
    <mesh_term>Umirolimus</mesh_term>
  </intervention_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/NCT03307213
org study id: 17EU02
nct id: NCT03307213
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study aims to demonstrate that the BioFreedom™ Cobalt Chromium Drug Coated Stent is
      non-inferior to the market authorized BioFreedom™ Stainless Steel Stent with respective to
      efficacy and shows a similar safety profile.
The BioFreedom™ QCA trial is designed to evaluate the safety and efficacy of the BioFreedom™
      CoCr DCS coronary stent system compared to the Biofreedom™ stainless steel DCS coronary stent
      system, in a randomized controlled trial on an all-comers patient population.

      The primary objective is to measure non-inferiority of the BioFreedom™ CoCr stent compared to
      BioFreedom™ DCS as measured by the difference in angiographically measured late lumen loss at
      9 months, and the main secondary endpoint is to assess safety as measured by MACE and ST. Two
      hundred (200) patients will be randomized 1:1 to either stent, allowing for a direct
      comparison, and will be followed-up to 2 years to measure for late MACE and ST events.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients will be randomised to one of the treatment arms to receive either the BioFreedom™ SS or the BioFreedom™ CoCr stent.
primary purpose: Treatment
masking: Single (Participant)
measure: In-stent late lumen loss (LLL) at 9 months
time frame: 9 months
description: In-stent late lumen loss (LLL) assessed by quantitative coronary angiography (QCA) at 9 months
measure: Cardiac Death
time frame: 1, 9, 12 and 24 months
description: Cardiac Death
measure: Myocardial infarction
time frame: 1, 9, 12 and 24 months
description: Myocardial infarction
measure: MACE
time frame: 1, 9, 12 and 24 months
description: MACE defined as cardiac death, myocardial infarction and clinically indicated
arm group label: BioFreedom™CoCr
arm group type: Experimental
description: Patients with CAD will receive the BioFreedom™CoCr stent if randomised to this arm.
arm group label: BioFreedom™ SS
arm group type: Active Comparator
description: Patients with CAD will receive the BioFreedom™SS stent if randomised to this arm.
intervention type: Device
intervention name: BioFreedom™ CoCr Biolimus A9™ stent
description: Stent implantation
arm group label: BioFreedom™CoCr
intervention type: Device
intervention name: BioFreedom™ SS Biolimus A9™ stent
description: Stent implantation
arm group label: BioFreedom™ SS
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Manel Sabate, Dr.
role: Principal Investigator
affiliation: Hospital Clinic of Barcelona
facility: 
facility: 
country: Denmark
country: Spain
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Myocardial Infarction
mesh term: Infarction
mesh term: Death
mesh term: Sirolimus
mesh term: Umirolimus
sharing ipd: No