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The European Bifurcation Club Left Main Study (EBC MAIN)

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ClinicalTrials.gov Identifier: NCT02497014
Recruitment Status : Recruiting
First Posted : July 14, 2015
Last Update Posted : March 8, 2016
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
European Cardiovascular Research Center

Tracking Information
First Submitted Date  ICMJE July 1, 2015
First Posted Date  ICMJE July 14, 2015
Last Update Posted Date March 8, 2016
Study Start Date  ICMJE February 2016
Estimated Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2015)
Composite of Death, Myocardial infarction and Target Lesion Revascularisation [ Time Frame: 1 year ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02497014 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2015)
  • Death [ Time Frame: 1 year ]
  • Myocardial Infarction [ Time Frame: 1 year ]
  • Target Lesion Revascularization [ Time Frame: 1 year ]
  • Angina status [ Time Frame: 1 year ]
  • Stent thrombosis [ Time Frame: 1 year ]
  • Death [ Time Frame: 3 years ]
  • Myocardial Infarction [ Time Frame: 3 years ]
  • Target Lesion Revascularization [ Time Frame: 3 years ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: July 13, 2015)
  • Procedure success by assessing a composite of the number of guidewires, balloons and stents opened or used and procedural time. [ Time Frame: up to 18 months ]
  • Technical success by assessing a composite of the number of guidewires, balloons and stents opened or used and procedural time. [ Time Frame: up to 18 months ]
  • Number of procedural and in-hospital Major adverse Cardiac Events (MACE) [ Time Frame: up to 18 months ]
  • Procedure duration [ Time Frame: intraoperative ]
  • Fluoroscopy by assessing a composite of the number of guidewires, balloons and stents opened or used and procedural time [ Time Frame: up to 18 months ]
  • X-ray dose [ Time Frame: up to 18 months ]
  • Economic evaluation by assessing all procedural costs for each stenting strategy [ Time Frame: up to 18 months ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE The European Bifurcation Club Left Main Study
Official Title  ICMJE The European Bifurcation Club Left Main Study: A Randomised Comparison of Single Versus Dual Stent Implantation for Distal Left Main True Coronary Bifurcation Lesions
Brief Summary The objective of the study is to investigate clinical outcomes following single versus dual stenting strategies for the treatment of true bifurcation distal left main coronary artery lesions.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Percutaneous Transluminal Coronary Angioplasty
  • Coronary Artery Disease
Intervention  ICMJE
  • Device: 1 Stent
    Stenting of main vessel should be undertaken with a wire jailed in the side vessel to preserve side vessel flow and access. Stent diameter should be chosen according to diameter of the main vessel immediately distal to the bifurcation. Distal left main should be dilated with a short non-compliant balloon. Side vessel should be rewired and a kissing balloon inflation should be undertaken. Balloon sizes should be according to the diameter of the main and side vessel with individual high pressure inflation followed by a final lower pressure kiss dilatation. Proximal stented portion in the left main coronary artery should be dilated to full expansion using either low pressure dilatation of the kissing balloon pair or a separate individual balloon. It is preferred that non-compliant balloons should be used to limit overstretching of vessels. In case of specific situations described in the protocol the operator may choose to implant a side vessel stent, using same process as described above.
  • Device: 2 Stents
    Coronary guide wires should be passed to LAD and Cx/intermediate arteries respectively. One should be designated the main vessel and one should be designated the side vessel. The planned dual stent technique is at the discretion of the operator but should be one of culotte, minicrush, T or TAP. If a crush procedure is chosen, it should ideally be of the DK variety. Stent diameter should be chosen according to the diameter of the vessel immediately distal to the bifurcation. Wire jail, POT, non-compliant balloons, high pressure individual "ostial" dilatations and final dilatation of the stented proximal left main should be used in accordance with the advice of the EBC. Further treatment to proximal or distal aspects of the main vessel or side vessel can be continued at the discretion of the operator. At any stage, proximal or distal dissections may be treated as required with further stent implantations. At any stage, post-dilatations may be undertaken to optimise stent expansion.
Study Arms  ICMJE
  • Experimental: 1 Stent
    Patients who are going to receive 1 stent in the main vessel and the side vessel will be treated with kissing ballon inflation
    Intervention: Device: 1 Stent
  • Experimental: 2 Stents
    Patients who are going to receive 2 stents in both vessels
    Intervention: Device: 2 Stents
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: July 13, 2015)
450
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE August 2020
Estimated Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Patients must meet ALL of the inclusion criteria:

  • Bifurcation distal left main stem stenosis >50% and

    • Ischaemic symptoms, or
    • Positive non-invasive imaging for ischaemia, or
    • Positive FFR, or
    • LMS IVUS MLA <6mm2
  • Left main diameter ≤5.75mm
  • True bifurcation lesion type 1,1,1 or 0,1,1
  • LAD and Cx diameter both >2.75mm
  • Unprotected left main
  • Patient ≥18 years old

Exclusion Criteria:

  • STEMI <72 hours preceding
  • Cardiogenic shock
  • Chronic total occlusion of either vessel
  • >2 other coronary lesions planned for treatment
  • SYNTAX score for planned lesions to be treated >32
  • LMS trifurcation if all vessels are ≥2.75mm diameter
  • Either bifurcation vessel not suitable for stenting
  • Platelet count ≤50 x 10^9/mm3
  • Left ventricular ejection fraction ≤20%
  • Patient life expectancy less than 12 months
  • Participation in another investigational drug or device study
  • Patient unable to give informed consent
  • Women of child-bearing potential or lactating
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Patricia Tiago +33176739258 ptiago@cerc-europe.org
Listed Location Countries  ICMJE Denmark,   France,   Germany,   Italy,   Latvia,   Serbia,   Spain,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02497014
Other Study ID Numbers  ICMJE MED-03
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party European Cardiovascular Research Center
Study Sponsor  ICMJE European Cardiovascular Research Center
Collaborators  ICMJE Medtronic
Investigators  ICMJE
Principal Investigator: David Hildick-Smith, Dr Brighton and Sussex University Hospitals NHS Trust
PRS Account European Cardiovascular Research Center
Verification Date March 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP