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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Royal Sussex County Hospital.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Terumo Corporation
Information provided by (Responsible Party):
David Hildick-Smith, Royal Sussex County Hospital
ClinicalTrials.gov Identifier:
NCT01560455
First received: September 16, 2011
Last updated: March 21, 2012
Last verified: March 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 Royal Sussex County Hospital:

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


Secondary Outcome Measures:
  • Stent thrombosis [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Stent thrombosis


Estimated Enrollment: 200
Study Start Date: May 2011
Estimated Primary Completion Date: September 2013 (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
culotte
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01560455

Contacts
Contact: David Hildick-Smith, MD david.hildick-smith@bsuh.nhs.uk
Contact: Ute Windhovel ute.windhovel@cerc-europe.com

Locations
United Kingdom
Sussex Cardiac Centre Recruiting
Brighton, East Sussex, United Kingdom, BN2 1DE
Contact: Nina Cooter    44-1274-696955 ext 4049    nina.cooter@bsuh.nhs.uk   
Sponsors and Collaborators
Royal Sussex County Hospital
Terumo Corporation
  More Information

No publications provided

Responsible Party: David Hildick-Smith, Consultant Cardiologist, Royal Sussex County Hospital
ClinicalTrials.gov Identifier: NCT01560455     History of Changes
Other Study ID Numbers: EBC TWO
Study First Received: September 16, 2011
Last Updated: March 21, 2012
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by 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

ClinicalTrials.gov processed this record on September 18, 2014