<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/NCT03263858</url>
  </required_header>
  <id_info>
    <org_study_id>C1606</org_study_id>
    <nct_id>NCT03263858</nct_id>
  </id_info>
  <brief_title>Vascular Implant Safety and Efficacy Study</brief_title>
  <acronym>BIOVITESSE</acronym>
  <official_title>Vascular Implant Safety and Efficacy Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Biotronik CRC Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Biotronik AG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Biotronik CRC Inc.</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>
      Assessment of the safety and clinical performance of a coronary stent system in de novo&#xD;
      coronary artery lesions&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 14, 2017</start_date>
  <completion_date type="Actual">January 28, 2020</completion_date>
  <primary_completion_date type="Actual">November 4, 2019</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>
    <intervention_model_description>consecutive enrolment of cohort 1 (primary endpoint at 1 month), and cohort 2 (primary endpoint at 9 months)</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Strut coverage cohort 1</measure>
    <time_frame>1 month</time_frame>
    <description>Strut coverage will be assessed by OCT analysis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>In stent late lumen loss cohort 2</measure>
    <time_frame>9 months</time_frame>
    <description>Late lumen loss with will be assessed by central QCA assessment</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">66</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>Cohort 1 and 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Stent</intervention_name>
    <description>Implantation of coronary stent in de novo coronary artery lesions</description>
    <arm_group_label>Cohort 1 and 2</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Subject is &gt; 18 years and &lt; 85 years old&#xD;
&#xD;
          2. Written subject informed consent&#xD;
&#xD;
          3. Subjects with stable or unstable angina pectoris or documented silent ischemia or&#xD;
             hemodynamically stable NSTEMI patients&#xD;
&#xD;
          4. Subject is eligible for percutaneous coronary intervention (PCI)&#xD;
&#xD;
          5. Subject is acceptable candidate for coronary artery bypass surgery&#xD;
&#xD;
          6. Subject is eligible for Dual Anti Platelet Therapy (DAPT)&#xD;
&#xD;
          7. Subjects with a maximum of two single discrete de novo lesions in two separate native&#xD;
             coronary arteries that can be treated with the study stent during the index procedure&#xD;
&#xD;
          8. Reference vessel diameter of 3.0 mm to 3.8 mm by visual estimation.&#xD;
&#xD;
          9. Target lesion length up to 22 mm by visual estimation.&#xD;
&#xD;
         10. Target lesion with ≥ 50% and &lt; 100% stenosis by visual estimation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Left main coronary artery disease&#xD;
&#xD;
          2. Three-vessel coronary artery disease at the time of index procedure&#xD;
&#xD;
          3. Angiographic evidence of thrombus in target vessel&#xD;
&#xD;
          4. Chronic total occlusion&#xD;
&#xD;
          5. Heavily calcified or extremely tortuous lesions that would prevent complete inflation&#xD;
             of a pre-dilatation balloon&#xD;
&#xD;
          6. Bifurcation lesion requiring side branch intervention, if side branches &gt; 2mm in&#xD;
             diameter are involved&#xD;
&#xD;
          7. Ostial lesions (within 5 mm of vessel origin)&#xD;
&#xD;
          8. In-stent restenosis&#xD;
&#xD;
          9. Lesions with prior treatment with a drug coated balloon (DCB)&#xD;
&#xD;
         10. Target lesion is located in or supplied by an arterial or venous bypass graft&#xD;
&#xD;
         11. Target lesion requires treatment with. rotational atherectomy&#xD;
&#xD;
         12. Proximal or distal to the target lesion located stenosis that might require future&#xD;
             revascularization or impede run off detected during diagnostic angiography&#xD;
&#xD;
         13. Previous treatment of target vessel within 9 months of index-procedure&#xD;
&#xD;
         14. Patients with cardiogenic shock&#xD;
&#xD;
         15. Documented left ventricular ejection fraction (LVEF) ≤ 30%&#xD;
&#xD;
         16. Impaired renal function (serum creatinine &gt; 2.5 mg/dl or 221 mmol/l, determined within&#xD;
             72 hours prior to intervention)&#xD;
&#xD;
         17. Hemodynamically unstable NSTEMI or STEMI within 72 hours prior to index procedure&#xD;
&#xD;
         18. Cerebrovascular event (within 3 months of index procedure)&#xD;
&#xD;
         19. Subject is receiving oral or intravenous immuno-suppressive therapy (inhaled steroids&#xD;
             are allowed) or has known life-limiting immunosuppressive or autoimmune disease (e.g.&#xD;
             human immunodeficiency virus, systemic lupus erythematosus, but not diabetes mellitus)&#xD;
&#xD;
         20. Known allergies to: Acetylsalicylic Acid (ASA), heparin, contrast medium, sirolimus,&#xD;
             or similar drugs, exipients or the stent material&#xD;
&#xD;
         21. Triple anticoagulation therapy&#xD;
&#xD;
         22. Life expectancy less than 1 year&#xD;
&#xD;
         23. Pregnant or breast-feeding females or females who intend to become pregnant during the&#xD;
             time of the study&#xD;
&#xD;
         24. Inability to understand or read the informed consent form&#xD;
&#xD;
         25. Subject is currently participating in another study with an investigational device or&#xD;
             an investigational drug and has not reached the primary endpoint yet&#xD;
&#xD;
         26. In the investigators opinion subjects will not be able to comply with the follow-up&#xD;
             requirements&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University Hospital Bern</name>
      <address>
        <city>Bern</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpiteaux Universitaires Genève (HUG)</name>
      <address>
        <city>Genève</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire Vaudois (CHUV)</name>
      <address>
        <city>Lausanne</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Cardiocentro Ticino</name>
      <address>
        <city>Lugano</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University Hospital Zürich</name>
      <address>
        <city>Zürich</city>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>August 21, 2017</study_first_submitted>
  <study_first_submitted_qc>August 23, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 28, 2017</study_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</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/NCT03263858
org study id: C1606
nct id: NCT03263858
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Assessment of the safety and clinical performance of a coronary stent system in de novo
      coronary artery lesions
allocation: N/A
intervention model: Single Group Assignment
intervention model description: consecutive enrolment of cohort 1 (primary endpoint at 1 month), and cohort 2 (primary endpoint at 9 months)
primary purpose: Treatment
masking: None (Open Label)
measure: Strut coverage cohort 1
time frame: 1 month
description: Strut coverage will be assessed by OCT analysis
measure: In stent late lumen loss cohort 2
time frame: 9 months
description: Late lumen loss with will be assessed by central QCA assessment
arm group label: Cohort 1 and 2
arm group type: Experimental
intervention type: Device
intervention name: Stent
description: Implantation of coronary stent in de novo coronary artery lesions
arm group label: Cohort 1 and 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Coronary Artery Disease
sharing ipd: No