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

This study has been completed.
Terumo Corporation
Information provided by (Responsible Party):
David Hildick-Smith, Royal Sussex County Hospital Identifier:
First received: September 16, 2011
Last updated: March 11, 2016
Last verified: March 2016
This study will examine use of two-stent versus one-stent techniques for patients with large calibre bifurcation lesions including significant side branch disease.

Condition Intervention Phase
Coronary Disease Device: single stent Device: two stent Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The European Bifurcation Coronary Study; A Randomised Comparison Of Provisional T-Stenting Versus A Systematic Two Stent Strategy In Large Calibre True Bifurcations

Further study details as provided by David Hildick-Smith, Royal Sussex County Hospital:

Primary Outcome Measures:
  • Composite primary endpoint (Death, MI, TVR) [ Time Frame: 12 months ]
    Death Myocardial infarction Target Vessel Revascularisation

Secondary Outcome Measures:
  • Stent thrombosis [ Time Frame: 12 months ]
    Stent thrombosis

Estimated Enrollment: 200
Study Start Date: May 2011
Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: single stent
single stent
Device: single stent
single stent
Other Name: Terumo Nobori stent
Active Comparator: dual stent
dual stent (culotte)
Device: two stent
Other Name: Terumo Nobori stent

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.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01560455

United Kingdom
Sussex Cardiac Centre
Brighton, East Sussex, United Kingdom, BN2 1DE
Sponsors and Collaborators
Royal Sussex County Hospital
Terumo Corporation
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: David Hildick-Smith, Consultant Cardiologist, Royal Sussex County Hospital Identifier: NCT01560455     History of Changes
Other Study ID Numbers: EBC TWO
Study First Received: September 16, 2011
Last Updated: March 11, 2016

Keywords provided by David Hildick-Smith, Royal Sussex County Hospital:

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arterial Occlusive Diseases processed this record on September 21, 2017