European Bifurcation Club Trial - Two-stent Versus One-stent Technique for Large Bifurcation Lesions

Phase 3

Completed

• Conditions: Coronary Disease

• Registration Number: NCT01560455
• Lead Sponsor: Royal Sussex County Hospital

Brief Summary

This study will examine use of two-stent versus one-stent techniques for patients with large calibre bifurcation lesions including significant side branch disease.

Detailed Description

Treatment of bifurcation coronary lesions remains a difficult area, in which best practice is yet to be established. Prior to the era of drug-eluting stents, the limited data which existed suggested that a strategy of stenting the main vessel, with balloon angioplasty alone of the side-branch if required was superior to stenting both vessels.

Randomised trials of "all-comer" bifurcation lesions have now established that there is no advantage to systematic dual drug-eluting stent strategies. However, these trials included patients with no disease in the side branch, and small side branch vessels.

Expert consensus suggests that "large" bifurcations with significant ostial side branch disease still merit a systematic total lesion coverage stent technique. This trial therefore is designed to assess the hypothesis that large true bifurcations with significant side branch ostial disease are more successfully treated with a systematic culotte technique than with the provisional T approach.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-09-16
• Study First Submitted QC: 2012-03-21
• Study First Posted: 2012-03-22
• Primary Completion: 2014-09
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-11
• Last Update Posted: 2016-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• "True" coronary bifurcation lesion (i.e. >50% lesion in both main vessel and side branch) requiring revascularisation
• Main vessel ≥ 2.5mm diameter (visual inspection)
• Side branch ≥ 2.5mm diameter (visual inspection)
• Side branch ostial lesion ≥5mm length
• Patient ≥18 years old
• Females of childbearing potential: -ve pregnancy test

Exclusion Criteria

• Acute ST elevation myocardial infarction
• Cardiogenic shock
• Left main stem lesion of haemodynamic significance
• Chronic total occlusion of either vessel
• Additional Type C lesions requiring PCI
• Either bifurcation vessel not suitable for stenting
• Platelet count ≤50 x 109/mm3
• Left ventricular ejection fraction ≤20%
• Patient life expectancy less than 12 months
• Known allergies to aspirin, clopidogrel, heparin, stainless steel, intravenous contrast (severe), or stent drug elutant
• Participation in another investigational drug or device study
• Patient unable to give informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Composite primary endpoint (Death, MI, TVR)	12 months	Death Myocardial infarction Target Vessel Revascularisation

Secondary Outcome Measures

Name	Time	Method
Stent thrombosis	12 months	Stent thrombosis

Trial Locations

Locations (1)

Sussex Cardiac Centre; 🇬🇧 Brighton, East Sussex, United Kingdom