NCT01560455

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

The European Bifurcation Coronary Study; A Randomised Comparison Of Provisional T-Stenting Versus A Systematic Two Stent Strategy In Large Calibre True Bifurcations

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Royal Sussex County Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Coronary Disease

Interventions

Type	Name	Description
DEVICE	single stent	single stent
DEVICE	two stent	culotte

Timeline

• Start date: 2011-05-01
• Primary completion: 2014-09-01
• First posted: 2012-03-22
• Last updated: 2016-03-14

Locations

1 site across 1 country: United Kingdom