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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

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.

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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.

Conditions

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Coronary Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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single stent

Group Type ACTIVE_COMPARATOR

single stent

Intervention Type DEVICE

single stent

dual stent

dual stent (culotte)

Group Type ACTIVE_COMPARATOR

two stent

Intervention Type DEVICE

culotte

Interventions

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single stent

Intervention Type DEVICE

two stent

culotte

Intervention Type DEVICE

Other Intervention Names

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Terumo Nobori stent Terumo Nobori stent

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No