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

Coronary Disease Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01560455
• Other study ID #: EBC TWO
• Status: Completed
• Phase: Phase 3
• First received: September 16, 2011
• Last updated: March 11, 2016
• Start date: May 2011

Study information

• Verified date: March 2016
• Source: Royal Sussex County Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease

Intervention

Device:
• single stent
single stent
• two stent
culotte

Locations

Country	Name	City	State
United Kingdom	Sussex Cardiac Centre	Brighton	East Sussex

Sponsors (2)

Lead Sponsor	Collaborator
Royal Sussex County Hospital	Terumo Corporation

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composite primary endpoint (Death, MI, TVR)	Death Myocardial infarction Target Vessel Revascularisation	12 months	Yes
Secondary	Stent thrombosis	Stent thrombosis	12 months	Yes