Skip to main content
MedPathMedPath Home
Clinical Trials/NCT02497014
NCT02497014
Unknown
Not Applicable

The European Bifurcation Club Left Main Study: A Randomised Comparison of Single Versus Dual Stent Implantation for Distal Left Main True Coronary Bifurcation Lesions

European Cardiovascular Research Center24 sites in 8 countries450 target enrollmentFebruary 2016
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
ConditionsPercutaneous Transluminal Coronary AngioplastyCoronary Artery Disease

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Percutaneous Transluminal Coronary Angioplasty
Sponsor
European Cardiovascular Research Center
Enrollment
450
Locations
24
Primary Endpoint
Composite of Death, Myocardial infarction and Target Lesion Revascularisation
Last Updated
10 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

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.

Registry
clinicaltrials.gov
Start Date
February 2016
End Date
August 2020
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
European Cardiovascular Research Center
Responsible Party
Sponsor

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

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

Outcomes

Primary Outcomes

Composite of Death, Myocardial infarction and Target Lesion Revascularisation

Time Frame: 1 year

Secondary Outcomes

  • Myocardial Infarction(3 years)
  • Stent thrombosis(1 year)
  • Angina status(1 year)
  • Death(3 years)
  • Target Lesion Revascularization(3 years)

Study Sites (24)

Loading locations...

Similar Trials

Completed
Phase 3
European Bifurcation Club Trial - Two-stent Versus One-stent Technique for Large Bifurcation LesionsCoronary Disease
NCT01560455Royal Sussex County Hospital200
Completed
Not Applicable
Unilateral Stenting Versus Bilateral Stenting for Malignant Hilar Biliary ObstructionCholangiocarcinomaGallbladder CarcinomaHepatocellular Carcinoma
NCT02649712Xuzhou Central Hospital72
Recruiting
Not Applicable
TWIN2WIN (Double Stent (DS-EVT) Versus Primary Thrombectomy With One Stent (SS-EVT))Acute Ischemic Stroke
NCT05632458Hospital Universitari Vall d'Hebron Research Institute180
Completed
Not Applicable
STRATEGY for Left Main Coronary Bifurcation Lesion IICoronary Artery Disease
NCT01798433Samsung Medical Center200
Recruiting
Not Applicable
A Study on Optimal Biliary Drainage and Improvement of Gastrointestinal Dyspepsia in Patients with Simultaneous Biliary and Duodenal StrictureGastric outlet obstruction and biliary obstruction
JPRN-UMIN000043183ational Cancer Center Hospital27