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

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ClinicalTrials.gov Identifier: NCT01560455
Recruitment Status : Completed
First Posted : March 22, 2012
Last Update Posted : March 14, 2016
Sponsor:
Collaborator:
Terumo Corporation
Information provided by (Responsible Party):
David Hildick-Smith, Royal Sussex County Hospital

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.

Condition or disease Intervention/treatment Phase
Coronary Disease Device: single stent Device: two stent Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
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
Study Start Date : May 2011
Actual Primary Completion Date : September 2014

Arm Intervention/treatment
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
culotte
Other Name: Terumo Nobori stent



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


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



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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01560455


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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: David Hildick-Smith, Consultant Cardiologist, Royal Sussex County Hospital
ClinicalTrials.gov Identifier: NCT01560455     History of Changes
Other Study ID Numbers: EBC TWO
First Posted: March 22, 2012    Key Record Dates
Last Update Posted: March 14, 2016
Last Verified: March 2016

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

Additional relevant MeSH terms:
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases