The European Bifurcation Club Left Main Study (EBC MAIN)

The European Bifurcation Club Left Main Study: A Randomised Comparison of Single Versus Dual Stent Implantation for Distal Left Main True Coronary Bifurcation Lesions

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Artery Disease; Percutaneous Transluminal Coronary Angioplasty
• Intervention / Treatment: Device: 1 Stent; Device: 2 Stents

• Study Type: Interventional
• Enrollment (Anticipated): 450
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Aarhus, Denmark, 8200
    • Active, not recruiting
    • Aarhus University Hospital
  • Copenhagen, Denmark, 2100
    • Active, not recruiting
    • Rigshospitalet Copenhagen University Hospital
• France
  • Fontaine-lès-Dijon, France, 21121
    • Not yet recruiting
    • Clinique de Fontaine
    • Contact: Edda Calabro
    • Principal Investigator: Philippe Brunel
  • Lyon, France, 69500
    • Not yet recruiting
    • HCL CHU Luis Pradel
    • Principal Investigator: Gérard Finet
  • Massy, France, 91300
    • Not yet recruiting
    • Hopital Jacques Cartier
    • Contact: Severine Roger
    • Principal Investigator: Thomas Hovasse, Dr
  • Rouen, France, 76000
    • Not yet recruiting
    • Clinique Saint Hilaire
    • Contact: Françoise Hupel
    • Principal Investigator: René Koning
  • Toulouse, France, 31076
    • Not yet recruiting
    • Clinique Pasteur
    • Principal Investigator: Jean Fajadet
    • Contact: Frédéric Petit
  • Toulouse, France, 31403
    • Not yet recruiting
    • CHU Rangueil
    • Contact: Jacqueline Cahuzac; Phone Number: 0033 5 61 32 33 45; Email: Cahuzac.j@chu-toulouse.fr
    • Contact: Ludovic Lacassagne; Phone Number: 0033 5 61 32 33 45; Email: Ludo.lacassagne@gmail.com
    • Principal Investigator: Didier Carrié, Prof
• Germany
  • Bad Krozingen, Germany, 79189
    • Not yet recruiting
    • Herzzentrum Bad Krozingen
    • Contact: Gudrun Dietsche; Phone Number: +49 76 33 402 5213; Email: Gudrun.Dietsche@herzzentrum.de
    • Contact: Johanna Korb; Phone Number: +49 7633 402 5211; Email: ohanna.korb@herzzentrum.de
    • Sub-Investigator: Miroslaw Ferenc, Dr med
  • Essen, Germany, 45138
    • Recruiting
    • Elisabeth Krankenhaus Essen
    • Contact: Vanessa Reuter
    • Principal Investigator: Christoph Naber
• Italy
  • Catania, Italy, 95124
    • Not yet recruiting
    • University of Catania - Ferrarotto Hospital
    • Principal Investigator: Corrado Tamburino
    • Contact: Laura Basile
  • Milano, Italy, 20132
    • Not yet recruiting
    • Ospedale San Raffaele
    • Contact: Vega Rusconi
    • Principal Investigator: Alaide Chieffo
  • Roma, Italy, 00168
    • Not yet recruiting
    • Universita Cattolica del Sacre Cuore
    • Principal Investigator: Francesco Burzotta
• Latvia
  • Riga, Latvia, 1002
    • Active, not recruiting
    • Pauls Stradins Clinical University Hospital
• Serbia
  • Belgrade, Serbia, 11000
    • Active, not recruiting
    • Clinical Center of Serbia
• Spain
  • Barcelona, Spain, 08003
    • Recruiting
    • Hospital del Mar
    • Contact: Paula Cabrero Cereto
    • Principal Investigator: Beatriz Vaquerizo, Dr
  • Barcelona, Spain, 08006
    • Active, not recruiting
    • Hospital Clinic De Barcelona
  • Barcelona, Spain, 08025
    • Active, not recruiting
    • Hospital Sant Pau i Sant Creu
  • Cordoba, Spain, 14004
    • Not yet recruiting
    • Hospital de la Reina Sofia
    • Contact: Eva Cebrian
    • Principal Investigator: Manuel Pan Alvarez Ossorio
• United Kingdom
  • Belfast, United Kingdom, BT97AB
    • Not yet recruiting
    • Belfast City Hospital
    • Principal Investigator: Mark Spence
  • Brighton, United Kingdom
    • Recruiting
    • Royal Sussex County Hospital
    • Contact: Nicola Skipper
    • Principal Investigator: David Hildick-Smith, David
  • London, United Kingdom, SE1 7EH
    • Not yet recruiting
    • St Thomas Hospital
    • Contact: Lucy Clack
    • Principal Investigator: Simon Redwood, Dr
  • Newcastle Upon Tyne, United Kingdom, NE7 7DN
    • Not yet recruiting
    • Freeman Hospital
    • Contact: Bijal Patel
    • Principal Investigator: Mohaned Egred, Dr
  • Oxford, United Kingdom, OX3 9DU
    • Not yet recruiting
    • John Radcliffe Hospital
    • Principal Investigator: Adrian Banning
    • Contact: Ellie Corps

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Composite of Death, Myocardial infarction and Target Lesion Revascularisation	1 year

Secondary Outcome Measures

Outcome Measure	Time Frame
Death	3 years
Death	1 year
Stent thrombosis	1 year
Myocardial Infarction	1 year
Target Lesion Revascularization	1 year
Angina status	1 year
Myocardial Infarction	3 years
Target Lesion Revascularization	3 years

Other Outcome Measures

Outcome Measure	Time Frame
Procedure duration	intraoperative
Procedure success by assessing a composite of the number of guidewires, balloons and stents opened or used and procedural time.	up to 18 months
Technical success by assessing a composite of the number of guidewires, balloons and stents opened or used and procedural time.	up to 18 months
Number of procedural and in-hospital Major adverse Cardiac Events (MACE)	up to 18 months
Fluoroscopy by assessing a composite of the number of guidewires, balloons and stents opened or used and procedural time	up to 18 months
X-ray dose	up to 18 months
Economic evaluation by assessing all procedural costs for each stenting strategy	up to 18 months

Collaborators and Investigators

• Sponsor: European Cardiovascular Research Center
• Collaborators: Medtronic
• Investigators: Principal Investigator: David Hildick-Smith, Dr, Brighton and Sussex University Hospitals NHS Trust

Publications and helpful links

General Publications

• Hildick-Smith D, Egred M, Banning A, Brunel P, Ferenc M, Hovasse T, Wlodarczak A, Pan M, Schmitz T, Silvestri M, Erglis A, Kretov E, Lassen JF, Chieffo A, Lefevre T, Burzotta F, Cockburn J, Darremont O, Stankovic G, Morice MC, Louvard Y. The European bifurcation club Left Main Coronary Stent study: a randomized comparison of stepwise provisional vs. systematic dual stenting strategies (EBC MAIN). Eur Heart J. 2021 Oct 1;42(37):3829-3839. doi: 10.1093/eurheartj/ehab283.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): August 1, 2020

Study Registration Dates

• First Submitted: July 1, 2015
• First Submitted That Met QC Criteria: July 13, 2015
• First Posted (Estimate): July 14, 2015

Study Record Updates

• Last Update Posted (Estimate): March 8, 2016
• Last Update Submitted That Met QC Criteria: March 7, 2016
• Last Verified: March 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: MED-03

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO