The European Bifurcation Club Left Main Study

Coronary Artery Disease Clinical Trial

— 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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02497014
• Other study ID #: MED-03
• Status: Recruiting
• Phase: N/A
• First received: July 1, 2015
• Last updated: March 7, 2016
• Start date: February 2016
• Est. completion date: August 2020

Study information

• Verified date: March 2016
• Source: European Cardiovascular Research Center
• Contact: Patricia Tiago
• Phone: +33176739258
• Email: ptiago[@]cerc-europe.org
• Is FDA regulated: No
• Health authority: Denmark: The National Committee on Health Research EthicsDenmark: The Regional Committee on Biomedical Research EthicsFrance: Conseil National de l'Ordre des MédecinsFrance: Commission nationale de l'informatique et des libertésFrance: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santéItaly: Ethics CommitteeLatvia: State Agency of MedicinesSerbia: Ethics CommitteeSpain: Ethics CommitteeUnited Kingdom: Research Ethics CommitteeGermany: Ethics CommissionSerbia: Medicines and Medical Devices Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: August 2020
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Percutaneous Transluminal Coronary Angioplasty

Intervention

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.
• 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.

Locations

Country	Name	City	State
Denmark	Aarhus University Hospital	Aarhus
Denmark	Rigshospitalet Copenhagen University Hospital	Copenhagen
France	Clinique de Fontaine	Fontaine-lès-Dijon
France	HCL CHU Luis Pradel	Lyon
France	Hopital Jacques Cartier	Massy
France	Clinique Saint Hilaire	Rouen
France	CHU Rangueil	Toulouse
France	Clinique Pasteur	Toulouse
Germany	Herzzentrum Bad Krozingen	Bad Krozingen
Germany	Elisabeth Krankenhaus Essen	Essen
Italy	University of Catania - Ferrarotto Hospital	Catania
Italy	Ospedale San Raffaele	Milano
Italy	Universita Cattolica del Sacre Cuore	Roma
Latvia	Pauls Stradins Clinical University Hospital	Riga
Serbia	Clinical Center of Serbia	Belgrade
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital del Mar	Barcelona
Spain	Hospital Sant Pau i Sant Creu	Barcelona
Spain	Hospital de la Reina Sofia	Cordoba
United Kingdom	Belfast City Hospital	Belfast
United Kingdom	Royal Sussex County Hospital	Brighton
United Kingdom	St Thomas Hospital	London
United Kingdom	Freeman Hospital	Newcastle Upon Tyne
United Kingdom	John Radcliffe Hospital	Oxford

Sponsors (2)

Lead Sponsor	Collaborator
European Cardiovascular Research Center	Medtronic

Countries where clinical trial is conducted

Denmark,  France,  Germany,  Italy,  Latvia,  Serbia,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Procedure success by assessing a composite of the number of guidewires, balloons and stents opened or used and procedural time.		up to 18 months	No
Other	Technical success by assessing a composite of the number of guidewires, balloons and stents opened or used and procedural time.		up to 18 months	No
Other	Number of procedural and in-hospital Major adverse Cardiac Events (MACE)		up to 18 months	No
Other	Procedure duration		intraoperative	No
Other	Fluoroscopy by assessing a composite of the number of guidewires, balloons and stents opened or used and procedural time		up to 18 months	No
Other	X-ray dose		up to 18 months	No
Other	Economic evaluation by assessing all procedural costs for each stenting strategy		up to 18 months	No
Primary	Composite of Death, Myocardial infarction and Target Lesion Revascularisation		1 year	No
Secondary	Death		1 year	No
Secondary	Myocardial Infarction		1 year	No
Secondary	Target Lesion Revascularization		1 year	No
Secondary	Angina status		1 year	No
Secondary	Stent thrombosis		1 year	No
Secondary	Death		3 years	No
Secondary	Myocardial Infarction		3 years	No
Secondary	Target Lesion Revascularization		3 years	No