The European Bifurcation Club Left Main Study

Not Applicable

• Conditions: Percutaneous Transluminal Coronary Angioplasty; Coronary Artery Disease
• Interventions: Device: 1 Stent; Device: 2 Stents

• Registration Number: NCT02497014
• Lead Sponsor: European Cardiovascular Research Center

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-07-01
• Study First Submitted QC: 2015-07-13
• Study First Posted: 2015-07-14
• Study Start: 2016-02
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-07
• Last Update Posted: 2016-03-08
• Primary Completion: 2018-08
• Study Completion: 2020-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1 Stent	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
2 Stents	2 Stents	Patients who are going to receive 2 stents in both vessels

Primary Outcome Measures

Name	Time	Method
Composite of Death, Myocardial infarction and Target Lesion Revascularisation	1 year

Secondary Outcome Measures

Name	Time	Method
Myocardial Infarction	3 years
Stent thrombosis	1 year
Angina status	1 year
Death	3 years
Target Lesion Revascularization	3 years

Trial Locations

Locations (24)

Hopital Jacques Cartier; 🇫🇷 Massy, France

Clinique Saint Hilaire; 🇫🇷 Rouen, France

Clinique Pasteur; 🇫🇷 Toulouse, France

Elisabeth Krankenhaus Essen; 🇩🇪 Essen, Germany

CHU Rangueil; 🇫🇷 Toulouse, France

Herzzentrum Bad Krozingen; 🇩🇪 Bad Krozingen, Germany

Ospedale San Raffaele; 🇮🇹 Milano, Italy

University of Catania - Ferrarotto Hospital; 🇮🇹 Catania, Italy

Universita Cattolica del Sacre Cuore; 🇮🇹 Roma, Italy

Pauls Stradins Clinical University Hospital; 🇱🇻 Riga, Latvia

Clinical Center of Serbia; 🇷🇸 Belgrade, Serbia

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital de la Reina Sofia; 🇪🇸 Cordoba, Spain

Hospital Sant Pau i Sant Creu; 🇪🇸 Barcelona, Spain

Royal Sussex County Hospital; 🇬🇧 Brighton, United Kingdom

Belfast City Hospital; 🇬🇧 Belfast, United Kingdom

Freeman Hospital; 🇬🇧 Newcastle Upon Tyne, United Kingdom

St Thomas Hospital; 🇬🇧 London, United Kingdom

John Radcliffe Hospital; 🇬🇧 Oxford, United Kingdom

Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Rigshospitalet Copenhagen University Hospital; 🇩🇰 Copenhagen, Denmark

HCL CHU Luis Pradel; 🇫🇷 Lyon, France

Clinique de Fontaine; 🇫🇷 Fontaine-lès-Dijon, France