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The European Bifurcation Club Left Main Study (EBC MAIN)

Primary Purpose

Percutaneous Transluminal Coronary Angioplasty, Coronary Artery Disease

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
1 Stent
2 Stents
Sponsored by
European Cardiovascular Research Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Percutaneous Transluminal Coronary Angioplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Aarhus University Hospital
  • Rigshospitalet Copenhagen University Hospital
  • Clinique de Fontaine
  • HCL CHU Luis Pradel
  • Hopital Jacques Cartier
  • Clinique Saint Hilaire
  • Clinique Pasteur
  • CHU Rangueil
  • Herzzentrum Bad Krozingen
  • Elisabeth Krankenhaus EssenRecruiting
  • University of Catania - Ferrarotto Hospital
  • Ospedale San Raffaele
  • Universita Cattolica del Sacre Cuore
  • Pauls Stradins Clinical University Hospital
  • Clinical Center of Serbia
  • Hospital del MarRecruiting
  • Hospital Clinic de Barcelona
  • Hospital Sant Pau i Sant Creu
  • Hospital de la Reina Sofia
  • Belfast City Hospital
  • Royal Sussex County HospitalRecruiting
  • St Thomas Hospital
  • Freeman Hospital
  • John Radcliffe Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

1 Stent

2 Stents

Arm Description

Patients who are going to receive 1 stent in the main vessel and the side vessel will be treated with kissing ballon inflation

Patients who are going to receive 2 stents in both vessels

Outcomes

Primary Outcome Measures

Composite of Death, Myocardial infarction and Target Lesion Revascularisation

Secondary Outcome Measures

Death
Myocardial Infarction
Target Lesion Revascularization
Angina status
Stent thrombosis
Death
Myocardial Infarction
Target Lesion Revascularization

Full Information

First Posted
July 1, 2015
Last Updated
March 7, 2016
Sponsor
European Cardiovascular Research Center
Collaborators
Medtronic
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1. Study Identification

Unique Protocol Identification Number
NCT02497014
Brief Title
The European Bifurcation Club Left Main Study
Acronym
EBC MAIN
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 Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
August 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
European Cardiovascular Research Center
Collaborators
Medtronic

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Percutaneous Transluminal Coronary Angioplasty, Coronary Artery Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
450 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1 Stent
Arm Type
Experimental
Arm Description
Patients who are going to receive 1 stent in the main vessel and the side vessel will be treated with kissing ballon inflation
Arm Title
2 Stents
Arm Type
Experimental
Arm Description
Patients who are going to receive 2 stents in both vessels
Intervention Type
Device
Intervention Name(s)
1 Stent
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
2 Stents
Intervention Description
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.
Primary Outcome Measure Information:
Title
Composite of Death, Myocardial infarction and Target Lesion Revascularisation
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Death
Time Frame
1 year
Title
Myocardial Infarction
Time Frame
1 year
Title
Target Lesion Revascularization
Time Frame
1 year
Title
Angina status
Time Frame
1 year
Title
Stent thrombosis
Time Frame
1 year
Title
Death
Time Frame
3 years
Title
Myocardial Infarction
Time Frame
3 years
Title
Target Lesion Revascularization
Time Frame
3 years
Other Pre-specified Outcome Measures:
Title
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
Title
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
Title
Number of procedural and in-hospital Major adverse Cardiac Events (MACE)
Time Frame
up to 18 months
Title
Procedure duration
Time Frame
intraoperative
Title
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
Title
X-ray dose
Time Frame
up to 18 months
Title
Economic evaluation by assessing all procedural costs for each stenting strategy
Time Frame
up to 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia Tiago
Phone
+33176739258
Email
ptiago@cerc-europe.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Hildick-Smith, Dr
Organizational Affiliation
Brighton and Sussex University Hospitals NHS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Active, not recruiting
Facility Name
Rigshospitalet Copenhagen University Hospital
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Individual Site Status
Active, not recruiting
Facility Name
Clinique de Fontaine
City
Fontaine-lès-Dijon
ZIP/Postal Code
21121
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Edda Calabro
First Name & Middle Initial & Last Name & Degree
Philippe Brunel
Facility Name
HCL CHU Luis Pradel
City
Lyon
ZIP/Postal Code
69500
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gérard Finet
Facility Name
Hopital Jacques Cartier
City
Massy
ZIP/Postal Code
91300
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Severine Roger
First Name & Middle Initial & Last Name & Degree
Thomas Hovasse, Dr
Facility Name
Clinique Saint Hilaire
City
Rouen
ZIP/Postal Code
76000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Françoise Hupel
First Name & Middle Initial & Last Name & Degree
René Koning
Facility Name
Clinique Pasteur
City
Toulouse
ZIP/Postal Code
31076
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Frédéric Petit
First Name & Middle Initial & Last Name & Degree
Jean Fajadet
Facility Name
CHU Rangueil
City
Toulouse
ZIP/Postal Code
31403
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jacqueline Cahuzac
Phone
0033 5 61 32 33 45
Email
Cahuzac.j@chu-toulouse.fr
First Name & Middle Initial & Last Name & Degree
Ludovic Lacassagne
Phone
0033 5 61 32 33 45
Email
Ludo.lacassagne@gmail.com
First Name & Middle Initial & Last Name & Degree
Didier Carrié, Prof
Facility Name
Herzzentrum Bad Krozingen
City
Bad Krozingen
ZIP/Postal Code
79189
Country
Germany
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gudrun Dietsche
Phone
+49 76 33 402 5213
Email
Gudrun.Dietsche@herzzentrum.de
First Name & Middle Initial & Last Name & Degree
Johanna Korb
Phone
+49 7633 402 5211
Email
ohanna.korb@herzzentrum.de
First Name & Middle Initial & Last Name & Degree
Miroslaw Ferenc, Dr med
Facility Name
Elisabeth Krankenhaus Essen
City
Essen
ZIP/Postal Code
45138
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vanessa Reuter
First Name & Middle Initial & Last Name & Degree
Christoph Naber
Facility Name
University of Catania - Ferrarotto Hospital
City
Catania
ZIP/Postal Code
95124
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Basile
First Name & Middle Initial & Last Name & Degree
Corrado Tamburino
Facility Name
Ospedale San Raffaele
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vega Rusconi
First Name & Middle Initial & Last Name & Degree
Alaide Chieffo
Facility Name
Universita Cattolica del Sacre Cuore
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Burzotta
Facility Name
Pauls Stradins Clinical University Hospital
City
Riga
ZIP/Postal Code
1002
Country
Latvia
Individual Site Status
Active, not recruiting
Facility Name
Clinical Center of Serbia
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Active, not recruiting
Facility Name
Hospital del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paula Cabrero Cereto
First Name & Middle Initial & Last Name & Degree
Beatriz Vaquerizo, Dr
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08006
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital Sant Pau i Sant Creu
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Individual Site Status
Active, not recruiting
Facility Name
Hospital de la Reina Sofia
City
Cordoba
ZIP/Postal Code
14004
Country
Spain
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eva Cebrian
First Name & Middle Initial & Last Name & Degree
Manuel Pan Alvarez Ossorio
Facility Name
Belfast City Hospital
City
Belfast
ZIP/Postal Code
BT97AB
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mark Spence
Facility Name
Royal Sussex County Hospital
City
Brighton
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicola Skipper
First Name & Middle Initial & Last Name & Degree
David Hildick-Smith, David
Facility Name
St Thomas Hospital
City
London
ZIP/Postal Code
SE1 7EH
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lucy Clack
First Name & Middle Initial & Last Name & Degree
Simon Redwood, Dr
Facility Name
Freeman Hospital
City
Newcastle Upon Tyne
ZIP/Postal Code
NE7 7DN
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bijal Patel
First Name & Middle Initial & Last Name & Degree
Mohaned Egred, Dr
Facility Name
John Radcliffe Hospital
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ellie Corps
First Name & Middle Initial & Last Name & Degree
Adrian Banning

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34002215
Citation
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.
Results Reference
derived

Learn more about this trial

The European Bifurcation Club Left Main Study

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