<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/NCT02224235</url>
  </required_header>
  <id_info>
    <org_study_id>COBRA 2013-02</org_study_id>
    <nct_id>NCT02224235</nct_id>
  </id_info>
  <brief_title>COBRA SHIELD OCT Study</brief_title>
  <official_title>COBRA PZF™ Coronary Stent System in Native Coronary Arteries for Early Healing, Thrombus Inhibition, Endothelialization and Avoiding Long-term Dual Anti-platelet Therapy: OCT (Optical Coherence Tomography) Evaluation in Comparison With DES</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>CeloNova BioSciences, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>ClinLogix. LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>CeloNova BioSciences, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Phase one of this study is a prospective, randomized (2:1), pilot study that will evaluate&#xD;
      COBRA PzF vascular healing patterns and thrombus formation with Optical Coherence Tomography&#xD;
      (OCT) at 3 months after stent implantation in comparison with Resolute Integrity drug eluting&#xD;
      stent (DES). Patients in the COBRA PzF (Group 1) will receive dual anti platelets for one&#xD;
      week followed by aspirin, while patients implanted with ZES (Group 2), will receive Dual&#xD;
      anti-platelet therapy (DAPT) for at least 6 months followed by aspirin.&#xD;
&#xD;
      After the completion of Phase 1, Phase 2 will enroll 10 patients in the COBRA PzF (Group 3).&#xD;
      Patients in Group 3 will receive aspirin alone and have OCT at one month after the stent&#xD;
      procedure to evaluate COBRA PzF vascular healing patterns and thrombus formation at one month&#xD;
      follow up.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Phase one of this study is a prospective, randomized (2:1), pilot study that will evaluate&#xD;
      COBRA PzF vascular healing patterns and thrombus formation with Optical Coherence Tomography&#xD;
      (OCT) at 3 months after stent implantation in comparison with Resolute Integrity drug eluting&#xD;
      stent (DES). Patients in the COBRA PzF (Group 1) will receive dual anti platelets for one&#xD;
      week followed by aspirin, while patients implanted with ZES (Group 2), will receive Dual&#xD;
      anti-platelet therapy (DAPT) for at least 6 months followed by aspirin.&#xD;
&#xD;
      After the completion of Phase 1, Phase 2 will enroll 10 patients in the COBRA PzF (Group 3).&#xD;
      Patients in Group 3 will receive aspirin alone and have OCT at one month after the stent&#xD;
      procedure to evaluate COBRA PzF vascular healing patterns and thrombus formation at one month&#xD;
      follow up.&#xD;
&#xD;
      This study was terminated after enrollment of 8 patients due to insufficient enrollment&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Inadequate enrollment&#xD;
  </why_stopped>
  <start_date>June 2014</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Neointimal coverage of the stent as measured using OCT</measure>
    <time_frame>1 month</time_frame>
    <description>Neointimal coverage of the stent as measured using OCT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neointimal coverage of the stent as measured using OCT</measure>
    <time_frame>3 months</time_frame>
    <description>Neointimal coverage of the stent as measured using OCT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Presence of thrombus formation as measured by OCT</measure>
    <time_frame>1 month</time_frame>
    <description>Presence of thrombus formation as measured by OCT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Presence of thrombus formation as measured by OCT</measure>
    <time_frame>3 months</time_frame>
    <description>Presence of thrombus formation as measured by OCT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of uncovered struts as measured by OCT</measure>
    <time_frame>1 month</time_frame>
    <description>Proportion of uncovered struts as measured by OCT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Proportion of uncovered struts as measured by OCT</measure>
    <time_frame>3 months</time_frame>
    <description>Proportion of uncovered struts as measured by OCT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Presence of Malopposed struts as measured by OCT</measure>
    <time_frame>1 month</time_frame>
    <description>Presence of Malopposed struts as measured by OCT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Presence of Malopposed struts as measured by OCT</measure>
    <time_frame>3 months</time_frame>
    <description>Presence of Malopposed struts as measured by OCT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>In-stent neointimal thickness measured using OCT</measure>
    <time_frame>1 month</time_frame>
    <description>In-stent neointimal thickness measured using OCT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>In-stent neointimal thickness measured by OCT</measure>
    <time_frame>3 months</time_frame>
    <description>In-stent neointimal thickness measured by OCT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lumen area measured by OCT</measure>
    <time_frame>1 month</time_frame>
    <description>Lumen area measured by OCT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lumen area measured by OCT</measure>
    <time_frame>3 months</time_frame>
    <description>Lumen area measured by OCT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lumen Volume measured by OCT</measure>
    <time_frame>1 month</time_frame>
    <description>Lumen Volume measured by OCT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lumen Volume measured by OCT</measure>
    <time_frame>3 months</time_frame>
    <description>Lumen Volume measured by OCT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stent area measured by OCT</measure>
    <time_frame>1 month</time_frame>
    <description>Stent area measured by OCT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stent area measured by OCT</measure>
    <time_frame>3 months</time_frame>
    <description>Stent area measured by OCT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stent volume measured by OCT</measure>
    <time_frame>1 month</time_frame>
    <description>Stent volume measured by OCT</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Stent volume measured by OCT</measure>
    <time_frame>3 months</time_frame>
    <description>Stent volume measured by OCT</description>
  </primary_outcome>
  <other_outcome>
    <measure>In-stent late loss measured by angiography</measure>
    <time_frame>1 month</time_frame>
    <description>In-stent late loss measured by angiography</description>
  </other_outcome>
  <other_outcome>
    <measure>In-stent late loss measured by angiography</measure>
    <time_frame>3 months</time_frame>
    <description>In-stent late loss measured by angiography</description>
  </other_outcome>
  <other_outcome>
    <measure>In-segment late loss measured by angiography</measure>
    <time_frame>1 month</time_frame>
    <description>In-segment late loss measured by angiography</description>
  </other_outcome>
  <other_outcome>
    <measure>In-segment late loss measured by angiography</measure>
    <time_frame>3 months</time_frame>
    <description>In-segment late loss measured by angiography</description>
  </other_outcome>
  <other_outcome>
    <measure>In-stent percent diameter stenosis measured by angiography</measure>
    <time_frame>1 month</time_frame>
    <description>In-stent percent diameter stenosis (%DS) measured by angiography</description>
  </other_outcome>
  <other_outcome>
    <measure>In-stent percent diameter stenosis measured by angiography</measure>
    <time_frame>3 months</time_frame>
    <description>In-stent percent diameter stenosis (%DS) measured by angiography</description>
  </other_outcome>
  <other_outcome>
    <measure>In-segment percent diameter stenosis measured by angiography</measure>
    <time_frame>1 month</time_frame>
    <description>In-segment percent diameter stenosis measured by angiography (%DS) (within the 5 mm margins proximal and distal to stent)</description>
  </other_outcome>
  <other_outcome>
    <measure>In-segment percent diameter stenosis measured by angiography</measure>
    <time_frame>3 months</time_frame>
    <description>In-segment percent diameter stenosis measured by angiography (%DS) (within the 5 mm margins proximal and distal to stent)</description>
  </other_outcome>
  <other_outcome>
    <measure>In-stent binary stenosis measured by angiography</measure>
    <time_frame>1 month</time_frame>
    <description>In-stent binary stenosis measured by angiography</description>
  </other_outcome>
  <other_outcome>
    <measure>In-stent binary stenosis measured by angiography</measure>
    <time_frame>3 months</time_frame>
    <description>In-stent binary stenosis measured by angiography(stenosis of &gt; 50% of the reference vessel diameter)</description>
  </other_outcome>
  <other_outcome>
    <measure>In-segment binary stenosis measured by angiography</measure>
    <time_frame>1 month</time_frame>
    <description>In-segment binary stenosis measured by angiography (stenosis of &gt; 50% of the reference vessel diameter)</description>
  </other_outcome>
  <other_outcome>
    <measure>In-segment binary stenosis measured by angiography</measure>
    <time_frame>3 months</time_frame>
    <description>In-segment binary stenosis measured by angiography (stenosis of &gt; 50% of the reference vessel diameter)</description>
  </other_outcome>
  <other_outcome>
    <measure>In-stent minimum lumen diameter measured by angiography</measure>
    <time_frame>1 month</time_frame>
    <description>In-stent minimum lumen diameter (MLD) measured by angiography</description>
  </other_outcome>
  <other_outcome>
    <measure>n-stent minimum lumen diameter measured by angiography</measure>
    <time_frame>3 months</time_frame>
    <description>In-stent minimum lumen diameter (MLD) measured by angiography</description>
  </other_outcome>
  <other_outcome>
    <measure>In-segment minimum lumen diameter (MLD) measured by angiography</measure>
    <time_frame>1 month</time_frame>
    <description>In-segment MLD measured by angiography</description>
  </other_outcome>
  <other_outcome>
    <measure>In-segment minimum lumen diameter (MLD) measured by angiography</measure>
    <time_frame>3 months</time_frame>
    <description>In-segment MLD measured by angiography</description>
  </other_outcome>
  <other_outcome>
    <measure>Longitudinal stent deformation measured by angiography</measure>
    <time_frame>1 month</time_frame>
    <description>Longitudinal stent deformation measured by angiography</description>
  </other_outcome>
  <other_outcome>
    <measure>Longitudinal stent deformation measured by angiography</measure>
    <time_frame>3 months</time_frame>
    <description>Longitudinal stent deformation measured by angiography</description>
  </other_outcome>
  <other_outcome>
    <measure>Presence of stent fracture measured by angiography</measure>
    <time_frame>1 month</time_frame>
    <description>Presence of stent fracture measured by angiography</description>
  </other_outcome>
  <other_outcome>
    <measure>Presence of stent fracture measured by angiography</measure>
    <time_frame>3 months</time_frame>
    <description>Presence of stent fracture measured by angiography</description>
  </other_outcome>
  <other_outcome>
    <measure>All Deaths</measure>
    <time_frame>1 month</time_frame>
    <description>All Deaths from any cause post index procedure</description>
  </other_outcome>
  <other_outcome>
    <measure>All Deaths</measure>
    <time_frame>6 months</time_frame>
    <description>All Deaths from any cause post index procedure</description>
  </other_outcome>
  <other_outcome>
    <measure>All Deaths</measure>
    <time_frame>12 months</time_frame>
    <description>All Deaths from any cause post index procedure</description>
  </other_outcome>
  <other_outcome>
    <measure>Cardiac Death</measure>
    <time_frame>1 month</time_frame>
    <description>Death due to cardiac cause post index procedure</description>
  </other_outcome>
  <other_outcome>
    <measure>Cardiac Death</measure>
    <time_frame>6 months</time_frame>
    <description>Death due to cardiac cause post index procedure</description>
  </other_outcome>
  <other_outcome>
    <measure>Cardiac Death</measure>
    <time_frame>12 months</time_frame>
    <description>Death due to cardiac cause post index procedure</description>
  </other_outcome>
  <other_outcome>
    <measure>Major Adverse Cardiac Events</measure>
    <time_frame>1 month</time_frame>
    <description>Major Adverse Cardiac Events (MACE) defined as cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods</description>
  </other_outcome>
  <other_outcome>
    <measure>Major Adverse Cardiac Events</measure>
    <time_frame>6 months</time_frame>
    <description>Major Adverse Cardiac Events (MACE) defined as cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods</description>
  </other_outcome>
  <other_outcome>
    <measure>Major Adverse Cardiac Events</measure>
    <time_frame>12 months</time_frame>
    <description>Major Adverse Cardiac Events (MACE) defined as cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods</description>
  </other_outcome>
  <other_outcome>
    <measure>Myocardial Infarction</measure>
    <time_frame>1 month</time_frame>
    <description>Occurrence of myocardial infarction. Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQWMI).</description>
  </other_outcome>
  <other_outcome>
    <measure>Myocardial Infarction</measure>
    <time_frame>6 months</time_frame>
    <description>Occurrence of myocardial infarction. Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQWMI).</description>
  </other_outcome>
  <other_outcome>
    <measure>Myocardial Infarction</measure>
    <time_frame>12 months</time_frame>
    <description>Occurrence of myocardial infarction. Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQWMI).</description>
  </other_outcome>
  <other_outcome>
    <measure>Composite endpoint of cardiac death and MI</measure>
    <time_frame>1 month</time_frame>
    <description>Composite endpoint of Cardiac Death and MI</description>
  </other_outcome>
  <other_outcome>
    <measure>Composite endpoint of cardiac death and MI</measure>
    <time_frame>6 months</time_frame>
    <description>Composite endpoint of Cardiac Death and MI</description>
  </other_outcome>
  <other_outcome>
    <measure>Composite endpoint of cardiac death and MI</measure>
    <time_frame>12 months</time_frame>
    <description>Composite endpoint of Cardiac Death and MI</description>
  </other_outcome>
  <other_outcome>
    <measure>Clinically driven Target Lesion Revascularization</measure>
    <time_frame>1 month</time_frame>
    <description>Clinically driven TLR. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.</description>
  </other_outcome>
  <other_outcome>
    <measure>Clinically driven Target Lesion Revascularization</measure>
    <time_frame>6 months</time_frame>
    <description>Clinically driven TLR. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.</description>
  </other_outcome>
  <other_outcome>
    <measure>Clinically driven Target Lesion Revascularization</measure>
    <time_frame>12 months</time_frame>
    <description>Clinically driven TLR. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.</description>
  </other_outcome>
  <other_outcome>
    <measure>Clinically driven target vessel revascularization</measure>
    <time_frame>1 month</time_frame>
    <description>Clinically driven TVR. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself.</description>
  </other_outcome>
  <other_outcome>
    <measure>Clinically driven target vessel revascularization</measure>
    <time_frame>6 months</time_frame>
    <description>Clinically driven TVR. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself.</description>
  </other_outcome>
  <other_outcome>
    <measure>Clinically driven target vessel revascularization</measure>
    <time_frame>12 months</time_frame>
    <description>Clinically driven TVR. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself.</description>
  </other_outcome>
  <other_outcome>
    <measure>Occurrence of Stroke post index procedure</measure>
    <time_frame>1 month</time_frame>
    <description>Stroke (ischemic and hemorrhagic)</description>
  </other_outcome>
  <other_outcome>
    <measure>Occurrence of Stroke post index procedure</measure>
    <time_frame>6 months</time_frame>
    <description>Stroke (ischemic and hemorrhagic)</description>
  </other_outcome>
  <other_outcome>
    <measure>Occurrence of Stroke post index procedure</measure>
    <time_frame>12 months</time_frame>
    <description>Stroke (ischemic and hemorrhagic)</description>
  </other_outcome>
  <other_outcome>
    <measure>Acute success</measure>
    <time_frame>30 days</time_frame>
    <description>Device Success: Defined as the attainment of &lt; 30% final residual stenosis of the target lesion using only the COBRA PzFTM Coronary Stent System Lesion Success: Defined as the attainment of &lt; 30% final residual stenosis of the target lesion using any percutaneous method.&#xD;
Procedure Success: Attainment of &lt; 30% residual stenosis of the target lesion and no in-hospital MACE.</description>
  </other_outcome>
  <other_outcome>
    <measure>Bleeding or vascular complications</measure>
    <time_frame>At time of hospital discharge (expected average to be within 2 days of index procedure</time_frame>
    <description>Bleeding Complications: Defined as a procedure-related hemorrhagic event that requires a transfusion and/or surgical intervention.&#xD;
Vascular Complications may include pseudoaneurysm, arteriovenous fistula (AVF), peripheral ischemia/nerve injury, and vascular event requiring transfusion or surgical repair.</description>
  </other_outcome>
  <other_outcome>
    <measure>Stent Thrombosis</measure>
    <time_frame>3 months</time_frame>
    <description>Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the patient has left the catheterization laboratory.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Stable Angina</condition>
  <arm_group>
    <arm_group_label>Group 1- COBRA 1 week DAPT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>COBRA PzF coronary stent followed by dual anti-platelet therapy (DAPT) for one week</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2 - DES 6 month DAPT</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Resolute Integrity DES followed by dual anti-platelet therapy (DAPT) for at least 6 months</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3 - COBRA Aspirin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>COBRA PzF coronary stent followed by aspirin alone</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Aspirin</intervention_name>
    <description>75-325 mg q.d. aspirin until study completion (recommended indefinitely for stent patients)</description>
    <arm_group_label>Group 3 - COBRA Aspirin</arm_group_label>
    <other_name>Ascriptin Enteric</other_name>
    <other_name>Aspir 81</other_name>
    <other_name>Aspir-Low</other_name>
    <other_name>Bufferin</other_name>
    <other_name>Easprin</other_name>
    <other_name>Ecotrin</other_name>
    <other_name>Ecpirin</other_name>
    <other_name>Fasprin</other_name>
    <other_name>Halfprin</other_name>
    <other_name>Miniprin</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Resolute Integrity DES</intervention_name>
    <description>Resolute Integrity DES</description>
    <arm_group_label>Group 2 - DES 6 month DAPT</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>COBRA PzF</intervention_name>
    <arm_group_label>Group 1- COBRA 1 week DAPT</arm_group_label>
    <arm_group_label>Group 3 - COBRA Aspirin</arm_group_label>
    <other_name>COBRA PzF coronary stent system</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>DAPT</intervention_name>
    <description>At the discretion of the investigator as to which DAPT is administered (per local practice)</description>
    <arm_group_label>Group 1- COBRA 1 week DAPT</arm_group_label>
    <arm_group_label>Group 2 - DES 6 month DAPT</arm_group_label>
    <other_name>Dual Anti Platelet Therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient &gt;= 18 years old.&#xD;
&#xD;
          -  Eligible for percutaneous coronary intervention (PCI).&#xD;
&#xD;
          -  Patient provides written informed consent.&#xD;
&#xD;
          -  Patient is willing to comply with follow-up evaluation.&#xD;
&#xD;
          -  Acceptable candidate for coronary artery bypass graft (CABG) surgery.&#xD;
&#xD;
          -  Stable angina pectoris or a positive functional ischemia study.&#xD;
&#xD;
          -  Male or non-pregnant female patient&#xD;
&#xD;
          -  Patient indicated for elective stenting of up to 2 stenotic lesions in two separate&#xD;
             native coronary arteries.&#xD;
&#xD;
          -  Reference vessel &gt;=2.5 mm and&lt;= 4.0 mm in diameter by visual estimate.&#xD;
&#xD;
          -  Target lesion &lt;=20 mm in length by visual estimate.&#xD;
&#xD;
          -  Protected left main lesion with &gt;50% stenosis.&#xD;
&#xD;
          -  Target lesion stenosis &gt;= 70% and &lt; 100% by visual estimate OR Target lesion stenosis&#xD;
             &lt;70% who meet physiological criteria for revascularization (i.e. positive Fractional&#xD;
             Flow Reserve).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently enrolled in another investigational device or drug trial.&#xD;
&#xD;
          -  Previously enrolled in another stent trial within the prior 2 years.&#xD;
&#xD;
          -  ANY planned elective surgery or percutaneous intervention within the subsequent 3&#xD;
             months.&#xD;
&#xD;
          -  A previous coronary interventional procedure of any kind within 30 days prior to the&#xD;
             procedure.&#xD;
&#xD;
          -  The patient requires staged procedure of either the target or any non-target vessel&#xD;
             before OCT procedure at 3 months post-procedure.&#xD;
&#xD;
          -  The target lesion requires treatment with a device other than percutaneous&#xD;
             transluminal coronary angioplasty (PTCA) prior to stent placement.&#xD;
&#xD;
          -  Previous drug eluting stent (DES) or bare metal stent (BMS) deployment anywhere in the&#xD;
             target vessel.&#xD;
&#xD;
          -  Co-morbid condition(s) that could limit the patient's ability to participate in the&#xD;
             trial or to comply with follow-up requirements, or impact the scientific integrity of&#xD;
             the trial.&#xD;
&#xD;
          -  Concurrent medical condition with a life expectancy of less than 12 months.&#xD;
&#xD;
          -  Documented left ventricular ejection fraction (LVEF) &lt; 50% at the most recent&#xD;
             evaluation.&#xD;
&#xD;
          -  Patients with diagnosis of myocardial infarction (MI) within 72 hours (i.e. CK-MB must&#xD;
             be returned to normal prior to enrollment) or suspected acute MI at time of&#xD;
             enrollment.&#xD;
&#xD;
          -  Previous intervention in the target vessel.&#xD;
&#xD;
          -  History of cerebrovascular accident or transient ischemic attack in the last 6 months.&#xD;
&#xD;
          -  Leukopenia (leukocytes &lt; 3.5 x10^9 / liter).&#xD;
&#xD;
          -  Neutropenia (Absolute Neutrophil Count &lt; 1000/mm3) &lt;= 3 days prior to enrollment.&#xD;
&#xD;
          -  Thrombocytopenia (platelets &lt; 100,000/mm3) pre-procedure.&#xD;
&#xD;
          -  Active peptic ulcer or active GI bleeding.&#xD;
&#xD;
          -  History of bleeding diathesis or coagulopathy or inability to accept blood&#xD;
             transfusions.&#xD;
&#xD;
          -  Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin,&#xD;
             clopidogrel or ticlopidine, cobalt, nickel, L-605 Cobalt chromium alloy or sensitivity&#xD;
             to contrast media, which cannot be adequately pre-medicated.&#xD;
&#xD;
          -  Serum creatinine level &gt; 2.0 mg/dl within 7 days prior to index procedure.&#xD;
&#xD;
          -  Patients not responsive to Plavix/ aspirin and or unable to tolerate Plavix/ aspirin&#xD;
             for 6 month post procedure.&#xD;
&#xD;
          -  Patient on or may require anticoagulation therapy within 3 months of index procedure.&#xD;
&#xD;
          -  Flow limiting dissections observed on OCT&#xD;
&#xD;
          -  Significant tissue prolapse within the stent observed on OCT&#xD;
&#xD;
          -  Unprotected left main coronary artery disease&#xD;
&#xD;
          -  Target vessel with any lesions with greater than 60% diameter stenosis outside of a&#xD;
             range of 5 mm proximal and distal to the target lesion based on visual estimate or&#xD;
             on-line quantitative coronary arteriography (QCA).&#xD;
&#xD;
          -  Target lesion (or vessel) exhibiting an intraluminal thrombus (occupying &gt; 50% of the&#xD;
             true lumen diameter) at any time.&#xD;
&#xD;
          -  Lesion location that is aorto-ostial or within 5 mm of the origin of the left anterior&#xD;
             descending (LAD) or left circumflex (LCX).&#xD;
&#xD;
          -  Target lesion with side branches &gt; 2.0mm in diameter.&#xD;
&#xD;
          -  Target vessel is excessively tortuous (two bends &gt; 90˚ to reach the target lesion).&#xD;
&#xD;
          -  Target lesion is severely calcified.&#xD;
&#xD;
          -  Thrombolysis In Myocardial Infarction (TIMI) flow 0 or 1&#xD;
&#xD;
          -  Target lesion is in a bypass graft&#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>Pasi Karjalainen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Satakunta Central Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Satakunta Central Hospital</name>
      <address>
        <city>Pori</city>
        <zip>28500</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heart Center, Turku University Hospital</name>
      <address>
        <city>Turku</city>
        <zip>20520</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <removed_countries>
    <country>Colombia</country>
  </removed_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 21, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 25, 2014</study_first_posted>
  <disposition_first_submitted>July 8, 2016</disposition_first_submitted>
  <disposition_first_submitted_qc>July 8, 2016</disposition_first_submitted_qc>
  <disposition_first_posted type="Estimate">July 11, 2016</disposition_first_posted>
  <last_update_submitted>September 29, 2020</last_update_submitted>
  <last_update_submitted_qc>September 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Stable angina</keyword>
  <keyword>PCI</keyword>
  <keyword>Percutaneous Coronary Intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Angina, Stable</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aspirin</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted, but a results disposition has been submitted           -->
</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/NCT02224235
org study id: COBRA 2013-02
nct id: NCT02224235
lead sponsor: 
collaborator: 
has dmc: No
Phase one of this study is a prospective, randomized (2:1), pilot study that will evaluate
      COBRA PzF vascular healing patterns and thrombus formation with Optical Coherence Tomography
      (OCT) at 3 months after stent implantation in comparison with Resolute Integrity drug eluting
      stent (DES). Patients in the COBRA PzF (Group 1) will receive dual anti platelets for one
      week followed by aspirin, while patients implanted with ZES (Group 2), will receive Dual
      anti-platelet therapy (DAPT) for at least 6 months followed by aspirin.

      After the completion of Phase 1, Phase 2 will enroll 10 patients in the COBRA PzF (Group 3).
      Patients in Group 3 will receive aspirin alone and have OCT at one month after the stent
      procedure to evaluate COBRA PzF vascular healing patterns and thrombus formation at one month
      follow up.
Phase one of this study is a prospective, randomized (2:1), pilot study that will evaluate
      COBRA PzF vascular healing patterns and thrombus formation with Optical Coherence Tomography
      (OCT) at 3 months after stent implantation in comparison with Resolute Integrity drug eluting
      stent (DES). Patients in the COBRA PzF (Group 1) will receive dual anti platelets for one
      week followed by aspirin, while patients implanted with ZES (Group 2), will receive Dual
      anti-platelet therapy (DAPT) for at least 6 months followed by aspirin.

      After the completion of Phase 1, Phase 2 will enroll 10 patients in the COBRA PzF (Group 3).
      Patients in Group 3 will receive aspirin alone and have OCT at one month after the stent
      procedure to evaluate COBRA PzF vascular healing patterns and thrombus formation at one month
      follow up.

      This study was terminated after enrollment of 8 patients due to insufficient enrollment
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Neointimal coverage of the stent as measured using OCT
time frame: 1 month
description: Neointimal coverage of the stent as measured using OCT
measure: Neointimal coverage of the stent as measured using OCT
time frame: 3 months
description: Neointimal coverage of the stent as measured using OCT
measure: Presence of thrombus formation as measured by OCT
time frame: 1 month
description: Presence of thrombus formation as measured by OCT
measure: Presence of thrombus formation as measured by OCT
time frame: 3 months
description: Presence of thrombus formation as measured by OCT
measure: Proportion of uncovered struts as measured by OCT
time frame: 1 month
description: Proportion of uncovered struts as measured by OCT
measure: Proportion of uncovered struts as measured by OCT
time frame: 3 months
description: Proportion of uncovered struts as measured by OCT
measure: Presence of Malopposed struts as measured by OCT
time frame: 1 month
description: Presence of Malopposed struts as measured by OCT
measure: Presence of Malopposed struts as measured by OCT
time frame: 3 months
description: Presence of Malopposed struts as measured by OCT
measure: In-stent neointimal thickness measured using OCT
time frame: 1 month
description: In-stent neointimal thickness measured using OCT
measure: In-stent neointimal thickness measured by OCT
time frame: 3 months
description: In-stent neointimal thickness measured by OCT
measure: Lumen area measured by OCT
time frame: 1 month
description: Lumen area measured by OCT
measure: Lumen area measured by OCT
time frame: 3 months
description: Lumen area measured by OCT
measure: Lumen Volume measured by OCT
time frame: 1 month
description: Lumen Volume measured by OCT
measure: Lumen Volume measured by OCT
time frame: 3 months
description: Lumen Volume measured by OCT
measure: Stent area measured by OCT
time frame: 1 month
description: Stent area measured by OCT
measure: Stent area measured by OCT
time frame: 3 months
description: Stent area measured by OCT
measure: Stent volume measured by OCT
time frame: 1 month
description: Stent volume measured by OCT
measure: Stent volume measured by OCT
time frame: 3 months
description: Stent volume measured by OCT
measure: In-stent late loss measured by angiography
time frame: 1 month
description: In-stent late loss measured by angiography
measure: In-stent late loss measured by angiography
time frame: 3 months
description: In-stent late loss measured by angiography
measure: In-segment late loss measured by angiography
time frame: 1 month
description: In-segment late loss measured by angiography
measure: In-segment late loss measured by angiography
time frame: 3 months
description: In-segment late loss measured by angiography
measure: In-stent percent diameter stenosis measured by angiography
time frame: 1 month
description: In-stent percent diameter stenosis (%DS) measured by angiography
measure: In-stent percent diameter stenosis measured by angiography
time frame: 3 months
description: In-stent percent diameter stenosis (%DS) measured by angiography
measure: In-segment percent diameter stenosis measured by angiography
time frame: 1 month
description: In-segment percent diameter stenosis measured by angiography (%DS) (within the 5 mm margins proximal and distal to stent)
measure: In-segment percent diameter stenosis measured by angiography
time frame: 3 months
description: In-segment percent diameter stenosis measured by angiography (%DS) (within the 5 mm margins proximal and distal to stent)
measure: In-stent binary stenosis measured by angiography
time frame: 1 month
description: In-stent binary stenosis measured by angiography
measure: In-stent binary stenosis measured by angiography
time frame: 3 months
description: In-stent binary stenosis measured by angiography(stenosis of > 50% of the reference vessel diameter)
measure: In-segment binary stenosis measured by angiography
time frame: 1 month
description: In-segment binary stenosis measured by angiography (stenosis of > 50% of the reference vessel diameter)
measure: In-segment binary stenosis measured by angiography
time frame: 3 months
description: In-segment binary stenosis measured by angiography (stenosis of > 50% of the reference vessel diameter)
measure: In-stent minimum lumen diameter measured by angiography
time frame: 1 month
description: In-stent minimum lumen diameter (MLD) measured by angiography
measure: n-stent minimum lumen diameter measured by angiography
time frame: 3 months
description: In-stent minimum lumen diameter (MLD) measured by angiography
measure: In-segment minimum lumen diameter (MLD) measured by angiography
time frame: 1 month
description: In-segment MLD measured by angiography
measure: In-segment minimum lumen diameter (MLD) measured by angiography
time frame: 3 months
description: In-segment MLD measured by angiography
measure: Longitudinal stent deformation measured by angiography
time frame: 1 month
description: Longitudinal stent deformation measured by angiography
measure: Longitudinal stent deformation measured by angiography
time frame: 3 months
description: Longitudinal stent deformation measured by angiography
measure: Presence of stent fracture measured by angiography
time frame: 1 month
description: Presence of stent fracture measured by angiography
measure: Presence of stent fracture measured by angiography
time frame: 3 months
description: Presence of stent fracture measured by angiography
measure: All Deaths
time frame: 1 month
description: All Deaths from any cause post index procedure
measure: All Deaths
time frame: 6 months
description: All Deaths from any cause post index procedure
measure: All Deaths
time frame: 12 months
description: All Deaths from any cause post index procedure
measure: Cardiac Death
time frame: 1 month
description: Death due to cardiac cause post index procedure
measure: Cardiac Death
time frame: 6 months
description: Death due to cardiac cause post index procedure
measure: Cardiac Death
time frame: 12 months
description: Death due to cardiac cause post index procedure
measure: Major Adverse Cardiac Events
time frame: 1 month
description: Major Adverse Cardiac Events (MACE) defined as cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods
measure: Major Adverse Cardiac Events
time frame: 6 months
description: Major Adverse Cardiac Events (MACE) defined as cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods
measure: Major Adverse Cardiac Events
time frame: 12 months
description: Major Adverse Cardiac Events (MACE) defined as cardiac death, MI (Q wave and non-Q wave), emergent bypass surgery, or clinically driven target lesion revascularization (TLR) by percutaneous or surgical methods
measure: Myocardial Infarction
time frame: 1 month
description: Occurrence of myocardial infarction. Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQWMI).
measure: Myocardial Infarction
time frame: 6 months
description: Occurrence of myocardial infarction. Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQWMI).
measure: Myocardial Infarction
time frame: 12 months
description: Occurrence of myocardial infarction. Defined as either a Q wave MI (QWMI) or Non-Q wave MI (NQWMI).
measure: Composite endpoint of cardiac death and MI
time frame: 1 month
description: Composite endpoint of Cardiac Death and MI
measure: Composite endpoint of cardiac death and MI
time frame: 6 months
description: Composite endpoint of Cardiac Death and MI
measure: Composite endpoint of cardiac death and MI
time frame: 12 months
description: Composite endpoint of Cardiac Death and MI
measure: Clinically driven Target Lesion Revascularization
time frame: 1 month
description: Clinically driven TLR. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.
measure: Clinically driven Target Lesion Revascularization
time frame: 6 months
description: Clinically driven TLR. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.
measure: Clinically driven Target Lesion Revascularization
time frame: 12 months
description: Clinically driven TLR. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target lesion is defined as the treated segment from 5 mm proximal to the stent and to 5 mm distal to the stent.
measure: Clinically driven target vessel revascularization
time frame: 1 month
description: Clinically driven TVR. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself.
measure: Clinically driven target vessel revascularization
time frame: 6 months
description: Clinically driven TVR. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself.
measure: Clinically driven target vessel revascularization
time frame: 12 months
description: Clinically driven TVR. An independent angiographic core laboratory should verify that the severity of percent diameter stenosis meets requirements for clinical indication and will overrule in cases where investigator reports are not in agreement. The target vessel is defined as the entire major coronary vessel proximal and distal to the target lesion, which includes upstream and downstream branches and the target lesion itself.
measure: Occurrence of Stroke post index procedure
time frame: 1 month
description: Stroke (ischemic and hemorrhagic)
measure: Occurrence of Stroke post index procedure
time frame: 6 months
description: Stroke (ischemic and hemorrhagic)
measure: Occurrence of Stroke post index procedure
time frame: 12 months
description: Stroke (ischemic and hemorrhagic)
measure: Acute success
time frame: 30 days
description: Device Success: Defined as the attainment of < 30% final residual stenosis of the target lesion using only the COBRA PzFTM Coronary Stent System Lesion Success: Defined as the attainment of < 30% final residual stenosis of the target lesion using any percutaneous method.
Procedure Success: Attainment of < 30% residual stenosis of the target lesion and no in-hospital MACE.
measure: Bleeding or vascular complications
time frame: At time of hospital discharge (expected average to be within 2 days of index procedure
description: Bleeding Complications: Defined as a procedure-related hemorrhagic event that requires a transfusion and/or surgical intervention.
Vascular Complications may include pseudoaneurysm, arteriovenous fistula (AVF), peripheral ischemia/nerve injury, and vascular event requiring transfusion or surgical repair.
measure: Stent Thrombosis
time frame: 3 months
description: Stent Thrombosis should be reported as a cumulative value at the different time points and with the different separate time points. Time 0 is defined as the time point after the guiding catheter has been removed and the patient has left the catheterization laboratory.
arm group label: Group 1- COBRA 1 week DAPT
arm group type: Experimental
description: COBRA PzF coronary stent followed by dual anti-platelet therapy (DAPT) for one week
arm group label: Group 2 - DES 6 month DAPT
arm group type: Active Comparator
description: Resolute Integrity DES followed by dual anti-platelet therapy (DAPT) for at least 6 months
arm group label: Group 3 - COBRA Aspirin
arm group type: Experimental
description: COBRA PzF coronary stent followed by aspirin alone
intervention type: Drug
intervention name: Aspirin
description: 75-325 mg q.d. aspirin until study completion (recommended indefinitely for stent patients)
arm group label: Group 3 - COBRA Aspirin
other name: Ascriptin Enteric
other name: Aspir 81
other name: Aspir-Low
other name: Bufferin
other name: Easprin
other name: Ecotrin
other name: Ecpirin
other name: Fasprin
other name: Halfprin
other name: Miniprin
intervention type: Device
intervention name: Resolute Integrity DES
description: Resolute Integrity DES
arm group label: Group 2 - DES 6 month DAPT
intervention type: Device
intervention name: COBRA PzF
arm group label: Group 1- COBRA 1 week DAPT
arm group label: Group 3 - COBRA Aspirin
other name: COBRA PzF coronary stent system
intervention type: Drug
intervention name: DAPT
description: At the discretion of the investigator as to which DAPT is administered (per local practice)
arm group label: Group 1- COBRA 1 week DAPT
arm group label: Group 2 - DES 6 month DAPT
other name: Dual Anti Platelet Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Pasi Karjalainen, MD, PhD
role: Principal Investigator
affiliation: Satakunta Central Hospital
facility: 
facility: 
country: Finland
country: Colombia
responsible party type: Sponsor
mesh term: Angina, Stable
mesh term: Aspirin