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

March 11, 2016 updated by: David Hildick-Smith, Royal Sussex County Hospital

The European Bifurcation Coronary Study; A Randomised Comparison Of Provisional T-Stenting Versus A Systematic Two Stent Strategy In Large Calibre True Bifurcations

This study will examine use of two-stent versus one-stent techniques for patients with large calibre bifurcation lesions including significant side branch disease.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

200

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • East Sussex
      • Brighton, East Sussex, United Kingdom, BN2 1DE
        • Sussex Cardiac Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: single stent
Device: single stent
single stent
Other Names:
  • Terumo Nobori stent
Active Comparator: dual stent
dual stent (culotte)
Device: two stent
culotte
Other Names:
  • Terumo Nobori stent

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite primary endpoint (Death, MI, TVR)
Time Frame: 12 months
Death Myocardial infarction Target Vessel Revascularisation
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stent thrombosis
Time Frame: 12 months
Stent thrombosis
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Royal Sussex County Hospital

Collaborators

Terumo Corporation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

September 1, 2014

Study Registration Dates

First Submitted

September 16, 2011

First Submitted That Met QC Criteria

March 21, 2012

First Posted (Estimate)

March 22, 2012

Study Record Updates

Last Update Posted (Estimate)

March 14, 2016

Last Update Submitted That Met QC Criteria

March 11, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EBC TWO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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