<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/NCT02232815</url>
  </required_header>
  <id_info>
    <org_study_id>BSC-02</org_study_id>
    <nct_id>NCT02232815</nct_id>
  </id_info>
  <brief_title>CELTIC Bifurcation Study</brief_title>
  <official_title>A Randomized Multicentre Trial to Compare Outcomes for Patients With Ischaemic Heart Disease and Bifurcation Coronary Artery Lesions Who Are Treated With Xience or Synergy Stents</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>
      This study will examine outcomes for patients treated by planned culotte stenting and compare&#xD;
      outcomes with 2 different stent platforms, the next generation Synergy II and the Xience&#xD;
      Xpedition DES platforms.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2014</start_date>
  <completion_date type="Anticipated">December 2018</completion_date>
  <primary_completion_date type="Anticipated">December 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>Composite measure of Adverse events</measure>
    <time_frame>9 months</time_frame>
    <description>Composite of:&#xD;
Death&#xD;
Myocardial Infarction&#xD;
CVA&#xD;
Target Vessel Failure (Composite of Target Vessel Revascularization and Target Vessel Inadequacy)&#xD;
Definite or Probable stent thrombosis (ARC criteria [14])&#xD;
Binary angiographic restenosis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Technical success (deployment of stents in both branches with &lt;20% residual stenosis and kissing balloon inflation at end of procedure)</measure>
    <time_frame>Day 0, during procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total procedure time</measure>
    <time_frame>Day 0, during procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total radiation dose</measure>
    <time_frame>Day 0, during procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Need to use secondary equipment or manoeuvres to complete the case</measure>
    <time_frame>Day 0, during procedure</time_frame>
    <description>extra support guidewires, anchor balloons or mother &amp; daughter catheter</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evidence of longitudinal stent compression at index implantation</measure>
    <time_frame>Day 0, during procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evidence of stent fracture at angiographic follow-up</measure>
    <time_frame>Day 0, during procedure</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Composite measure of Adverse events</measure>
    <time_frame>24 months</time_frame>
    <description>Composite of:&#xD;
Death&#xD;
Myocardial Infarction&#xD;
CVA&#xD;
Target Vessel Failure (Composite of Target Vessel Revascularization and Target Vessel Inadequacy)&#xD;
Definite or Probable stent thrombosis (ARC criteria [14])</description>
  </secondary_outcome>
  <enrollment type="Anticipated">170</enrollment>
  <condition>Coronary Bifurcations</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients planed for culotte DES stenting&#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;
          -  Coronary artery disease requiring revascularization that is amenable to PCI&#xD;
&#xD;
          -  Medina 1,1,1 bifurcation lesion [13] with &gt;70% lesion in both the main vessel and the&#xD;
             side branch by visual assessment&#xD;
&#xD;
          -  Main branch and side branch ≥ 2.5mm in diameter by visual assessment&#xD;
&#xD;
          -  Both vessels require stenting in the opinion of the operator&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute myocardial infarction with ongoing ST-elevation&#xD;
&#xD;
          -  Cardiogenic shock&#xD;
&#xD;
          -  Lesion involves the left main coronary artery&#xD;
&#xD;
          -  Lesion involves bypass graft&#xD;
&#xD;
          -  Plan to treat &gt;1 other coronary vessel at the time of inclusion&#xD;
&#xD;
          -  Chronic total occlusion of any target vessel&#xD;
&#xD;
          -  Left ventricular ejection fraction &lt;20%&#xD;
&#xD;
          -  Requirement for ongoing haemodialysis&#xD;
&#xD;
          -  Life-expectancy limited to &lt;12 months due to co-morbid condition&#xD;
&#xD;
          -  Known allergy to Aspirin&#xD;
&#xD;
          -  Known allergy to Clopidorel and Prasugrel and Ticagrelor&#xD;
&#xD;
          -  Known allergy to stent drug elutant&#xD;
&#xD;
          -  Known allergy to any other component of either the Synergy II or Xience Xpedition&#xD;
             stents systems&#xD;
&#xD;
          -  Ongoing participation in another investigational device or drug study&#xD;
&#xD;
          -  Inability to provide informed consent&#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_contact>
    <last_name>David Foley</last_name>
    <phone>+35 1 809 3140</phone>
  </overall_contact>
  <location>
    <facility>
      <name>St Vincent's Hospital Dublin</name>
      <address>
        <city>Dublin</city>
        <zip>4</zip>
        <country>Ireland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Niall Mulvahill, Dr</last_name>
    </contact>
    <investigator>
      <last_name>Niall Mulvahill, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Belfast Health &amp; Social Care Trust</name>
      <address>
        <city>Belfast</city>
        <zip>BT8 8BH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Colm Hanratty, Dr</last_name>
    </contact>
    <investigator>
      <last_name>Colm Hanratty, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Bristol Royal Inﬁrmary</name>
      <address>
        <city>Bristol</city>
        <zip>BS2 8HW</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tom Johnson, Dr</last_name>
    </contact>
    <investigator>
      <last_name>Tom Johnson, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Edinburgh Royal Inﬁrmary</name>
      <address>
        <city>Edinburgh</city>
        <zip>EH16 4SA,</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nick Cruden</last_name>
    </contact>
    <investigator>
      <last_name>Nick Cruden</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Golden Jubilee</name>
      <address>
        <city>Glasgow</city>
        <zip>G81 4DY</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Keith Oldroyd, Prof</last_name>
    </contact>
    <investigator>
      <last_name>Keith Oldroyd, Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kings College</name>
      <address>
        <city>London</city>
        <zip>SE5 9RS,</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jonathan Hill, Dr</last_name>
    </contact>
    <investigator>
      <last_name>Jonathan Hill, Dr</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Ireland</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2016</verification_date>
  <study_first_submitted>August 25, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <last_update_submitted>September 6, 2016</last_update_submitted>
  <last_update_submitted_qc>September 6, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 7, 2016</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/NCT02232815
org study id: BSC-02
nct id: NCT02232815
lead sponsor: 
collaborator: 
This study will examine outcomes for patients treated by planned culotte stenting and compare
      outcomes with 2 different stent platforms, the next generation Synergy II and the Xience
      Xpedition DES platforms.
observational model: Cohort
time perspective: Prospective
measure: Composite measure of Adverse events
time frame: 9 months
description: Composite of:
Death
Myocardial Infarction
CVA
Target Vessel Failure (Composite of Target Vessel Revascularization and Target Vessel Inadequacy)
Definite or Probable stent thrombosis (ARC criteria [14])
Binary angiographic restenosis
measure: Technical success (deployment of stents in both branches with <20% residual stenosis and kissing balloon inflation at end of procedure)
time frame: Day 0, during procedure
measure: Total procedure time
time frame: Day 0, during procedure
measure: Total radiation dose
time frame: Day 0, during procedure
measure: Need to use secondary equipment or manoeuvres to complete the case
time frame: Day 0, during procedure
description: extra support guidewires, anchor balloons or mother & daughter catheter
measure: Evidence of longitudinal stent compression at index implantation
time frame: Day 0, during procedure
measure: Evidence of stent fracture at angiographic follow-up
time frame: Day 0, during procedure
measure: Composite measure of Adverse events
time frame: 24 months
description: Composite of:
Death
Myocardial Infarction
CVA
Target Vessel Failure (Composite of Target Vessel Revascularization and Target Vessel Inadequacy)
Definite or Probable stent thrombosis (ARC criteria [14])
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: David Foley
phone: +35 1 809 3140
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Ireland
country: United Kingdom
responsible party type: Sponsor