The European Bifurcation Club Left Main Study

NAUnknownINTERVENTIONAL
Enrollment

450

Participants

Timeline

Start Date

February 29, 2016

Primary Completion Date

August 31, 2018

Study Completion Date

August 31, 2020

Conditions
Percutaneous Transluminal Coronary AngioplastyCoronary Artery Disease
Interventions
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.

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."

Trial Locations (24)

1002

ACTIVE_NOT_RECRUITING

Pauls Stradins Clinical University Hospital, Riga

2100

ACTIVE_NOT_RECRUITING

Rigshospitalet Copenhagen University Hospital, Copenhagen

8200

ACTIVE_NOT_RECRUITING

Aarhus University Hospital, Aarhus

11000

ACTIVE_NOT_RECRUITING

Clinical Center of Serbia, Belgrade

14004

NOT_YET_RECRUITING

Hospital de la Reina Sofia, Córdoba

20132

NOT_YET_RECRUITING

Ospedale San Raffaele, Milan

21121

NOT_YET_RECRUITING

Clinique de Fontaine, Fontaine-lès-Dijon

31076

NOT_YET_RECRUITING

Clinique Pasteur, Toulouse

31403

NOT_YET_RECRUITING

CHU Rangueil, Toulouse

45138

RECRUITING

Elisabeth Krankenhaus Essen, Essen

69500

NOT_YET_RECRUITING

HCL CHU Luis Pradel, Lyon

76000

NOT_YET_RECRUITING

Clinique Saint Hilaire, Rouen

79189

NOT_YET_RECRUITING

Herzzentrum Bad Krozingen, Bad Krozingen

91300

NOT_YET_RECRUITING

Hopital Jacques Cartier, Massy

95124

NOT_YET_RECRUITING

University of Catania - Ferrarotto Hospital, Catania

00168

NOT_YET_RECRUITING

Universita Cattolica del Sacre Cuore, Roma

08003

RECRUITING

Hospital del Mar, Barcelona

08006

ACTIVE_NOT_RECRUITING

Hospital Clinic de Barcelona, Barcelona

08025

ACTIVE_NOT_RECRUITING

Hospital Sant Pau i Sant Creu, Barcelona

BT97AB

NOT_YET_RECRUITING

Belfast City Hospital, Belfast

Unknown

RECRUITING

Royal Sussex County Hospital, Brighton

SE1 7EH

NOT_YET_RECRUITING

St Thomas Hospital, London

NE7 7DN

NOT_YET_RECRUITING

Freeman Hospital, Newcastle upon Tyne

OX3 9DU

NOT_YET_RECRUITING

John Radcliffe Hospital, Oxford

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Medtronic

INDUSTRY

lead

European Cardiovascular Research Center

NETWORK