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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
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01560455
Acronym
EBC TWO
Enrollment
200
Registered
2012-03-22
Start date
2011-05-31
Completion date
Unknown
Last updated
2016-03-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Disease

Keywords

stent, bifurcation, coronary

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.

Interventions

DEVICEsingle stent

single stent

DEVICEtwo stent

culotte

Sponsors

Terumo Corporation
CollaboratorINDUSTRY
Royal Sussex County Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Composite primary endpoint (Death, MI, TVR)12 monthsDeath Myocardial infarction Target Vessel Revascularisation

Secondary

MeasureTime frameDescription
Stent thrombosis12 monthsStent thrombosis

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026