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CELTIC Bifurcation Study

Sponsor
European Cardiovascular Research Center (Other)
Overall Status
Unknown status
CT.gov ID
NCT02232815
Collaborator
Ceric Sàrl (Industry)
170
Enrollment
6
Locations
48
Duration (Months)
28.3
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    170 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    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
    Study Start Date :
    Dec 1, 2014
    Anticipated Primary Completion Date :
    Dec 1, 2016
    Anticipated Study Completion Date :
    Dec 1, 2018

    Outcome Measures

    Primary Outcome Measures

    1. Composite measure of Adverse events [9 months]

      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

    Secondary Outcome Measures

    1. Technical success (deployment of stents in both branches with <20% residual stenosis and kissing balloon inflation at end of procedure) [Day 0, during procedure]

    2. Total procedure time [Day 0, during procedure]

    3. Total radiation dose [Day 0, during procedure]

    4. Need to use secondary equipment or manoeuvres to complete the case [Day 0, during procedure]

      extra support guidewires, anchor balloons or mother & daughter catheter

    5. Evidence of longitudinal stent compression at index implantation [Day 0, during procedure]

    6. Evidence of stent fracture at angiographic follow-up [Day 0, during procedure]

    7. Composite measure of Adverse events [24 months]

      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])

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Male or female patient >18 years old

    • Females of childbearing potential with a negative pregnancy test

    • Coronary artery disease requiring revascularization that is amenable to PCI

    • Medina 1,1,1 bifurcation lesion [13] with >70% lesion in both the main vessel and the side branch by visual assessment

    • Main branch and side branch ≥ 2.5mm in diameter by visual assessment

    • Both vessels require stenting in the opinion of the operator

    Exclusion Criteria:

    • Acute myocardial infarction with ongoing ST-elevation

    • Cardiogenic shock

    • Lesion involves the left main coronary artery

    • Lesion involves bypass graft

    • Plan to treat >1 other coronary vessel at the time of inclusion

    • Chronic total occlusion of any target vessel

    • Left ventricular ejection fraction <20%

    • Requirement for ongoing haemodialysis

    • Life-expectancy limited to <12 months due to co-morbid condition

    • Known allergy to Aspirin

    • Known allergy to Clopidorel and Prasugrel and Ticagrelor

    • Known allergy to stent drug elutant

    • Known allergy to any other component of either the Synergy II or Xience Xpedition stents systems

    • Ongoing participation in another investigational device or drug study

    • Inability to provide informed consent

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 St Vincent's Hospital Dublin Dublin Ireland 4
    2 Belfast Health & Social Care Trust Belfast United Kingdom BT8 8BH
    3 Bristol Royal Infirmary Bristol United Kingdom BS2 8HW
    4 Edinburgh Royal Infirmary Edinburgh United Kingdom EH16 4SA,
    5 Golden Jubilee Glasgow United Kingdom G81 4DY
    6 Kings College London United Kingdom SE5 9RS,

    Sponsors and Collaborators

    • European Cardiovascular Research Center
    • Ceric Sàrl

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    European Cardiovascular Research Center
    ClinicalTrials.gov Identifier:
    NCT02232815
    Other Study ID Numbers:
    • BSC-02
    First Posted:
    Sep 5, 2014
    Last Update Posted:
    Sep 7, 2016
    Last Verified:
    Sep 1, 2016

    Study Results

    No Results Posted as of Sep 7, 2016