<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/NCT02227771</url>
  </required_header>
  <id_info>
    <org_study_id>BSC-03</org_study_id>
    <nct_id>NCT02227771</nct_id>
  </id_info>
  <brief_title>Consistent CTO Trial</brief_title>
  <official_title>CONventional Antegrade vs Sub-Intimal Synergy sTENTing in Chronic Total Occlusions</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>European Cardiovascular Research Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ceric Sàrl</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>European Cardiovascular Research Center</source>
  <brief_summary>
    <textblock>
      The purpose of this study is to demonstrate that enhanced vascular healing with the Synergy&#xD;
      stent should minimize the risk of late aneurysm formation and potential clinical&#xD;
      complications but not at the cost of enhanced efficacy.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>December 2014</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2016</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>The primary stent endpoint is 12-month target vessel failure (TVF) rate</measure>
    <time_frame>12 months</time_frame>
    <description>The primary stent endpoint is 12-month target vessel failure (TVF) rate, defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or cardiac death.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The primary balloon endpoint is device procedural success</measure>
    <time_frame>1 month</time_frame>
    <description>Successful delivery of the Emerge Coronary Dilatation catherter across the lesion and Successful inflation and removal of the Emerge Coronary Dilatation catherter with absences of clinically significant vessel perforation or flow limiting vessel dissection, reduction in thrombolysis in myocardial infarction (TIMI) flow from baseline, clinically significant arrythmias requiring medical treatment or device intervention following dilatation with Emerge balloon and Achievment of final TIMLI 3 flow for the target lesion at the conclusion of the index procedure. The primary balloon endpoint will be evaluated in patients where an attempt to use an Emerge Coronary Dilatation catherter is made.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Target lesion revascularization (TLR) rate</measure>
    <time_frame>In hospital, 6 Months, 12 Months, 2 Years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target lesion failure (TLF) rate</measure>
    <time_frame>In hospital, 6 Months, 12 Months, 2 Years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target vessel revascularization (TVR) rate</measure>
    <time_frame>In hospital, 6 Months, 12 Months, 2 Years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Target vessel failure (TVF) rate</measure>
    <time_frame>In hospital, 6 Months, 12 Months, 2 Years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Myocardial infarction (MI, Q-wave and non-Q-wave) rate</measure>
    <time_frame>In hospital, 6 Months, 12 Months, 2 Years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac death rate</measure>
    <time_frame>In hospital, 6 Months, 12 Months, 2 Years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non-cardiac death rate</measure>
    <time_frame>In hospital, 6 Months, 12 Months, 2 Years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All death rate</measure>
    <time_frame>In hospital, 6 Months, 12 Months, 2 Years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cardiac death or MI rate</measure>
    <time_frame>In hospital, 6 Months, 12 Months, 2 Years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All death or MI rate</measure>
    <time_frame>In hospital, 6 Months, 12 Months, 2 Years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>All death/MI/TVR rate</measure>
    <time_frame>In hospital, 6 Months, 12 Months, 2 Years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent thrombosis rate (by ARC definitions)</measure>
    <time_frame>In hospital, 6 Months, 12 Months, 2 Years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Angina, dyspnoea and quality of life scores</measure>
    <time_frame>12 Months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-stent and in-segment percent diameter stenosis (%DS)</measure>
    <time_frame>Peri-procedural</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-stent and in-segment minimum lumen diameter (MLD)</measure>
    <time_frame>Peri-procedural</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acute gain</measure>
    <time_frame>Peri-procedural</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-stent and in-segment %DS</measure>
    <time_frame>12-Months Post-Index Procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-segment late loss</measure>
    <time_frame>12-Months Post-Index Procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-stent and in-segment binary restenosis rate</measure>
    <time_frame>12-Months Post-Index Procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-stent and in-segment MLD</measure>
    <time_frame>12-Months Post-Index Procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incomplete apposition</measure>
    <time_frame>Peri-procedural</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stent, vessel and lumen areas and volumes</measure>
    <time_frame>Peri-procedural</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Incomplete apposition</measure>
    <time_frame>12-Months Post-Index Procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Aneurysm formation</measure>
    <time_frame>12-Months Post-Index Procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Endothelial strut coverage percentage</measure>
    <time_frame>12-Months Post-Index Procedure</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">215</enrollment>
  <condition>Chronic Total Occlusion</condition>
  <arm_group>
    <arm_group_label>Patient with chronic total occlusion</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Percutaneous coronary intervention</intervention_name>
    <arm_group_label>Patient with chronic total occlusion</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who come to hospital for CTO and who met all the inclusion/eclusion criteria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female patient &gt;18 years old&#xD;
&#xD;
          -  Females of childbearing potential with a negative pregnancy test&#xD;
&#xD;
          -  Presence of Chronic Total Occlusion (CTO) that is known or presumed to be of at least&#xD;
             3 months in duration&#xD;
&#xD;
          -  Subject (or legal guardian) understands the trial requirements and the treatment&#xD;
             procedures and provides written informed consent&#xD;
&#xD;
          -  Attempt to implant at least one Synergy II stent has been made&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute myocardial infarction with ongoing ST-elevation&#xD;
&#xD;
          -  Cardiogenic shock&#xD;
&#xD;
          -  Left ventricular ejection fraction &lt;20%&#xD;
&#xD;
          -  Subject has one of the following (as assessed prior to the index procedure):&#xD;
&#xD;
        Other serious medical illness (e.g., cancer, congestive heart failure) with estimated life&#xD;
        expectancy of less than 24 months Current problems with substance abuse (e.g., alcohol,&#xD;
        cocaine, heroin, etc.) Planned procedure that may cause non-compliance with the protocol or&#xD;
        confound data interpretation&#xD;
&#xD;
          -  Subject is treated by dialysis or has a baseline serum creatinine level &gt;220 μmol/L&#xD;
             (2.5 mg/dL)&#xD;
&#xD;
          -  Known allergy to to contrast (that cannot be adequately premedicated) and/or the trial&#xD;
             stent system or protocol-required concomitant medications (e.g., platinum,&#xD;
             platinum-chromium alloy, stainless steel, everolimus or structurally related&#xD;
             compounds, polymer or individual components, all P2Y12 inhibitors, or aspirin)&#xD;
&#xD;
          -  Subject is participating in another investigational drug or device clinical trial that&#xD;
             has not reached its primary endpoint OR subject intends to participate in another&#xD;
             investigational drug or device clinical trial within 12 months after the index&#xD;
             procedure&#xD;
&#xD;
          -  Need for ongoing long-term anticoagulation&#xD;
&#xD;
          -  Subject has received an organ transplant or is on a waiting list for an organ&#xD;
             transplant&#xD;
&#xD;
          -  Subject is receiving or scheduled to receive chemotherapy within 30 days before or&#xD;
             after the index procedure&#xD;
&#xD;
          -  Planned CABG after the index procedure&#xD;
&#xD;
          -  Subject previously treated at any time with intravascular brachytherapy&#xD;
&#xD;
          -  Subject has a platelet count &lt;100,000 cells/mm3 or &gt;700,000 cells/mm3&#xD;
&#xD;
          -  Subject has a white blood cell (WBC) count &lt; 3,000 cells/mm3&#xD;
&#xD;
          -  Subject has documented or suspected liver disease, including laboratory evidence of&#xD;
             hepatitis&#xD;
&#xD;
          -  Subject has a clinically significant bleeding diathesis or coagulopathy or will refuse&#xD;
             blood transfusions&#xD;
&#xD;
          -  Subject has had a history of cerebrovascular accident (CVA) or transient ischemic&#xD;
             attack (TIA) within the past 6 months&#xD;
&#xD;
          -  Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding&#xD;
&#xD;
          -  Subject has severe symptomatic heart failure (i.e., NYHA class IV)&#xD;
&#xD;
          -  Subject with known intention to procreate within 12 months after the index procedure&#xD;
             (women of child-bearing potential who are sexually active must agree to use a reliable&#xD;
             method of contraception from the time of screening through 12 months after the index&#xD;
             procedure)&#xD;
&#xD;
          -  Subject is a woman who is pregnant or nursing (a pregnancy test must be performed&#xD;
             within 7 days prior to the index procedure in women of child-bearing potential)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Belfast Health &amp; Social Care Trust</name>
      <address>
        <city>Belfast</city>
        <zip>BT9 7AB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Bristol Royal Infirmary</name>
      <address>
        <city>Bristol</city>
        <zip>BS2 8HW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Edinburgh Royal Infirmary</name>
      <address>
        <city>Edinburgh</city>
        <zip>EH16 4SA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Golden Jubilee, Glasgow</name>
      <address>
        <city>Glasgow</city>
        <zip>G81 4DY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>London Chest Hospital,</name>
      <address>
        <city>London</city>
        <zip>E2 9JX</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kings College, London</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <removed_countries>
    <country>Ireland</country>
  </removed_countries>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>August 26, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 28, 2014</study_first_posted>
  <last_update_submitted>May 17, 2017</last_update_submitted>
  <last_update_submitted_qc>May 17, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT02227771
org study id: BSC-03
nct id: NCT02227771
lead sponsor: 
collaborator: 
The purpose of this study is to demonstrate that enhanced vascular healing with the Synergy
      stent should minimize the risk of late aneurysm formation and potential clinical
      complications but not at the cost of enhanced efficacy.
observational model: Cohort
time perspective: Prospective
measure: The primary stent endpoint is 12-month target vessel failure (TVF) rate
time frame: 12 months
description: The primary stent endpoint is 12-month target vessel failure (TVF) rate, defined as any ischemia-driven revascularization of the target vessel, MI (Q-wave and non-Q-wave) related to the target vessel or cardiac death.
measure: The primary balloon endpoint is device procedural success
time frame: 1 month
description: Successful delivery of the Emerge Coronary Dilatation catherter across the lesion and Successful inflation and removal of the Emerge Coronary Dilatation catherter with absences of clinically significant vessel perforation or flow limiting vessel dissection, reduction in thrombolysis in myocardial infarction (TIMI) flow from baseline, clinically significant arrythmias requiring medical treatment or device intervention following dilatation with Emerge balloon and Achievment of final TIMLI 3 flow for the target lesion at the conclusion of the index procedure. The primary balloon endpoint will be evaluated in patients where an attempt to use an Emerge Coronary Dilatation catherter is made.
measure: Target lesion revascularization (TLR) rate
time frame: In hospital, 6 Months, 12 Months, 2 Years
measure: Target lesion failure (TLF) rate
time frame: In hospital, 6 Months, 12 Months, 2 Years
measure: Target vessel revascularization (TVR) rate
time frame: In hospital, 6 Months, 12 Months, 2 Years
measure: Target vessel failure (TVF) rate
time frame: In hospital, 6 Months, 12 Months, 2 Years
measure: Myocardial infarction (MI, Q-wave and non-Q-wave) rate
time frame: In hospital, 6 Months, 12 Months, 2 Years
measure: Cardiac death rate
time frame: In hospital, 6 Months, 12 Months, 2 Years
measure: Non-cardiac death rate
time frame: In hospital, 6 Months, 12 Months, 2 Years
measure: All death rate
time frame: In hospital, 6 Months, 12 Months, 2 Years
measure: Cardiac death or MI rate
time frame: In hospital, 6 Months, 12 Months, 2 Years
measure: All death or MI rate
time frame: In hospital, 6 Months, 12 Months, 2 Years
measure: All death/MI/TVR rate
time frame: In hospital, 6 Months, 12 Months, 2 Years
measure: Stent thrombosis rate (by ARC definitions)
time frame: In hospital, 6 Months, 12 Months, 2 Years
measure: Angina, dyspnoea and quality of life scores
time frame: 12 Months
measure: In-stent and in-segment percent diameter stenosis (%DS)
time frame: Peri-procedural
measure: In-stent and in-segment minimum lumen diameter (MLD)
time frame: Peri-procedural
measure: Acute gain
time frame: Peri-procedural
measure: In-stent and in-segment %DS
time frame: 12-Months Post-Index Procedure
measure: In-segment late loss
time frame: 12-Months Post-Index Procedure
measure: In-stent and in-segment binary restenosis rate
time frame: 12-Months Post-Index Procedure
measure: In-stent and in-segment MLD
time frame: 12-Months Post-Index Procedure
measure: Incomplete apposition
time frame: Peri-procedural
measure: Stent, vessel and lumen areas and volumes
time frame: Peri-procedural
measure: Incomplete apposition
time frame: 12-Months Post-Index Procedure
measure: Aneurysm formation
time frame: 12-Months Post-Index Procedure
measure: Endothelial strut coverage percentage
time frame: 12-Months Post-Index Procedure
arm group label: Patient with chronic total occlusion
intervention type: Device
intervention name: Percutaneous coronary intervention
arm group label: Patient with chronic total occlusion
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: United Kingdom
country: Ireland
responsible party type: Sponsor