EBC MAIN: The European Bifurcation Club Left Main Study

Sponsor

European Cardiovascular Research Center (Other)

Overall Status

Unknown status

CT.gov ID

NCT02497014

Collaborator

Medtronic (Industry)

450

Enrollment

Locations

Arms

Duration (Months)

18.8

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Percutaneous Transluminal Coronary Angioplasty Coronary Artery Disease	Device: 1 Stent Device: 2 Stents	N/A

Study Design

Study Type:

Interventional

Anticipated 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 :

Feb 1, 2016

Anticipated Primary Completion Date :

Aug 1, 2018

Anticipated Study Completion Date :

Aug 1, 2020

Arms and Interventions

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.

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

Primary Outcome Measures

Composite of Death, Myocardial infarction and Target Lesion Revascularisation [1 year]

Secondary Outcome Measures

Death [1 year]
Myocardial Infarction [1 year]
Target Lesion Revascularization [1 year]
Angina status [1 year]
Stent thrombosis [1 year]
Death [3 years]
Myocardial Infarction [3 years]
Target Lesion Revascularization [3 years]

Other Outcome Measures

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]
Procedure duration [intraoperative]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Aarhus University Hospital	Aarhus	Denmark	8200
2	Rigshospitalet Copenhagen University Hospital	Copenhagen	Denmark	2100
3	Clinique de Fontaine	Fontaine-lès-Dijon	France	21121
4	HCL CHU Luis Pradel	Lyon	France	69500
5	Hopital Jacques Cartier	Massy	France	91300
6	Clinique Saint Hilaire	Rouen	France	76000
7	Clinique Pasteur	Toulouse	France	31076
8	CHU Rangueil	Toulouse	France	31403
9	Herzzentrum Bad Krozingen	Bad Krozingen	Germany	79189
10	Elisabeth Krankenhaus Essen	Essen	Germany	45138
11	University of Catania - Ferrarotto Hospital	Catania	Italy	95124
12	Ospedale San Raffaele	Milano	Italy	20132
13	Universita Cattolica del Sacre Cuore	Roma	Italy	00168
14	Pauls Stradins Clinical University Hospital	Riga	Latvia	1002
15	Clinical Center of Serbia	Belgrade	Serbia	11000
16	Hospital del Mar	Barcelona	Spain	08003
17	Hospital Clinic de Barcelona	Barcelona	Spain	08006
18	Hospital Sant Pau i Sant Creu	Barcelona	Spain	08025
19	Hospital de la Reina Sofia	Cordoba	Spain	14004
20	Belfast City Hospital	Belfast	United Kingdom	BT97AB
21	Royal Sussex County Hospital	Brighton	United Kingdom
22	St Thomas Hospital	London	United Kingdom	SE1 7EH
23	Freeman Hospital	Newcastle Upon Tyne	United Kingdom	NE7 7DN
24	John Radcliffe Hospital	Oxford	United Kingdom	OX3 9DU

Sponsors and Collaborators

European Cardiovascular Research Center
Medtronic

Investigators

Principal Investigator: David Hildick-Smith, Dr, Brighton and Sussex University Hospitals NHS Trust

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

European Cardiovascular Research Center

ClinicalTrials.gov Identifier:

NCT02497014

Other Study ID Numbers:

MED-03

First Posted:

Jul 14, 2015

Last Update Posted:

Mar 8, 2016

Last Verified:

Mar 1, 2016

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Additional relevant MeSH terms:

Coronary Artery Disease

Study Results

No Results Posted as of Mar 8, 2016