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

Primary Purpose

Coronary Disease

Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
single stent
two stent
Sponsored by
Royal Sussex County Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Disease focused on measuring stent, bifurcation, coronary

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sussex Cardiac Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

single stent

dual stent

Arm Description

single stent

dual stent (culotte)

Outcomes

Primary Outcome Measures

Composite primary endpoint (Death, MI, TVR)
Death Myocardial infarction Target Vessel Revascularisation

Secondary Outcome Measures

Stent thrombosis
Stent thrombosis

Full Information

First Posted
September 16, 2011
Last Updated
March 11, 2016
Sponsor
Royal Sussex County Hospital
Collaborators
Terumo Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01560455
Brief Title
European Bifurcation Club Trial - Two-stent Versus One-stent Technique for Large Bifurcation Lesions
Acronym
EBC TWO
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 Type
Interventional

2. Study Status

Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Royal Sussex County Hospital
Collaborators
Terumo Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Disease
Keywords
stent, bifurcation, coronary

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
single stent
Arm Type
Active Comparator
Arm Description
single stent
Arm Title
dual stent
Arm Type
Active Comparator
Arm Description
dual stent (culotte)
Intervention Type
Device
Intervention Name(s)
single stent
Other Intervention Name(s)
Terumo Nobori stent
Intervention Description
single stent
Intervention Type
Device
Intervention Name(s)
two stent
Other Intervention Name(s)
Terumo Nobori stent
Intervention Description
culotte
Primary Outcome Measure Information:
Title
Composite primary endpoint (Death, MI, TVR)
Description
Death Myocardial infarction Target Vessel Revascularisation
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Stent thrombosis
Description
Stent thrombosis
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Sussex Cardiac Centre
City
Brighton
State/Province
East Sussex
ZIP/Postal Code
BN2 1DE
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27578839
Citation
Hildick-Smith D, Behan MW, Lassen JF, Chieffo A, Lefevre T, Stankovic G, Burzotta F, Pan M, Ferenc M, Bennett L, Hovasse T, Spence MJ, Oldroyd K, Brunel P, Carrie D, Baumbach A, Maeng M, Skipper N, Louvard Y. The EBC TWO Study (European Bifurcation Coronary TWO): A Randomized Comparison of Provisional T-Stenting Versus a Systematic 2 Stent Culotte Strategy in Large Caliber True Bifurcations. Circ Cardiovasc Interv. 2016 Sep;9(9):e003643. doi: 10.1161/CIRCINTERVENTIONS.115.003643.
Results Reference
derived

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

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