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NCT00351260 Clinical Trial

BBC ONE - British Bifurcation Coronary Study

Stenosis Clinical Trial

— BBC ONE  

Official title:
British Bifurcation Coronary Study - Old, New and Evolving Strategies.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00351260
Other study ID # COREC2006
Secondary ID
Status Completed
Phase Phase 3
First received July 11, 2006
Last updated April 15, 2008
Start date January 2005
Est. completion date December 2007

Study information
Verified date March 2008
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

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 500
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

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

Related Conditions & MeSH terms

Intervention

Procedure:
• Coronary Angioplasty

Locations
Country Name City State
United Kingdom Royal Sussex County Hospital Brighton

Sponsors (1)
Lead Sponsor Collaborator
Royal Sussex County Hospital

Country where clinical trial is conducted

United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Death
Primary Myocardial infarction
Primary Target vessel revascularisation
Secondary Repeat angiography
Secondary Stent thrombosis
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