BBC ONE - British Bifurcation Coronary Study

Phase 3

Completed

• Conditions: Ischaemic Heart Diseases; Stenosis; Angina

• Registration Number: NCT00351260
• Lead Sponsor: Royal Sussex County Hospital

Brief Summary

The study aims to assess whether a SIMPLE or a COMPLEX strategy is best for the treatment of coronary bifurcation stenoses.

Detailed Description

500 patients will be randomised to either a SIMPLE strategy (provisional T stenting) or a COMPLEX strategy (crush or culotte stenting) with clinical follow-up at 9 months.

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2006-07-11
• Study First Submitted QC: 2006-07-11
• Study First Posted: 2006-07-12
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Status Verified: 2008-03
• Last Update Submitted: 2008-04-15
• Last Update Posted: 2008-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

>18 years

• Coronary Bifurcation Lesion requiring treatment

Exclusion Criteria

• Cardiogenic Shock
• Acute MI
• Additional type C lesion for Rx platelets <50
• LVEF <20%

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Death
Myocardial infarction
Target vessel revascularisation

Secondary Outcome Measures

Name	Time	Method
Repeat angiography
Stent thrombosis

Trial Locations

Locations (1)

Royal Sussex County Hospital; 🇬🇧 Brighton, United Kingdom