European Bifurcation Club Trial - Two-stent Versus One-stent Technique for Large Bifurcation Lesions (EBC TWO)

Royal Sussex County Hospital

Status and phase

Completed

Phase 3

Conditions

Coronary Disease

Treatments

Device: two stent

Device: single stent

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01560455

EBC TWO

Details and patient eligibility

About

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

Full 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.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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