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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Coronary Disease

Intervention / Treatment
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* Device: single stent
* Device: two stent


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: single stent<br>single stent | Device: single stent<br>* single stent<br>* Other names: Terumo Nobori stent;|
| Active Comparator: dual stent<br>dual stent (culotte) | Device: two stent<br>* culotte<br>* Other names: Terumo Nobori stent;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite primary endpoint (Death, MI, TVR) | Death Myocardial infarction Target Vessel Revascularisation | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent thrombosis | Stent thrombosis | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stent, bifurcation, coronary