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The European Bifurcation Club Left Main Study (EBC MAIN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02497014
Recruitment Status : Unknown
Verified March 2016 by European Cardiovascular Research Center.
Recruitment status was:  Recruiting
First Posted : July 14, 2015
Last Update Posted : March 8, 2016
Sponsor:
Collaborator:
Medtronic
Information provided by (Responsible Party):
European Cardiovascular Research Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Percutaneous Transluminal Coronary Angioplasty Coronary Artery Disease Device: 1 Stent Device: 2 Stents Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The European Bifurcation Club Left Main Study: A Randomised Comparison of Single Versus Dual Stent Implantation for Distal Left Main True Coronary Bifurcation Lesions
Study Start Date : February 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : August 2020
Arms and Interventions
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Arm Intervention/treatment
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
 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.
Experimental: 2 Stents
Patients who are going to receive 2 stents in both vessels
 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.


Outcome Measures
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Primary Outcome Measures :
  1. Composite of Death, Myocardial infarction and Target Lesion Revascularisation [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Death [ Time Frame: 1 year ]
  2. Myocardial Infarction [ Time Frame: 1 year ]
  3. Target Lesion Revascularization [ Time Frame: 1 year ]
  4. Angina status [ Time Frame: 1 year ]
  5. Stent thrombosis [ Time Frame: 1 year ]
  6. Death [ Time Frame: 3 years ]
  7. Myocardial Infarction [ Time Frame: 3 years ]
  8. Target Lesion Revascularization [ Time Frame: 3 years ]

Other Outcome Measures:
  1. 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 ]
  2. 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 ]
  3. Number of procedural and in-hospital Major adverse Cardiac Events (MACE) [ Time Frame: up to 18 months ]
  4. Procedure duration [ Time Frame: intraoperative ]
  5. 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 ]
  6. X-ray dose [ Time Frame: up to 18 months ]
  7. Economic evaluation by assessing all procedural costs for each stenting strategy [ Time Frame: up to 18 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02497014


Contacts
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Contact: Patricia Tiago +33176739258 ptiago@cerc-europe.org

Locations
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Sponsors and Collaborators
European Cardiovascular Research Center
Medtronic
Investigators
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Principal Investigator: David Hildick-Smith, Dr Brighton and Sussex University Hospitals NHS Trust
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: European Cardiovascular Research Center
ClinicalTrials.gov Identifier: NCT02497014    
Other Study ID Numbers: MED-03
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: March 8, 2016
Last Verified: March 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases