BBC ONE - British Bifurcation Coronary Study - Full Text View

Sponsored by:	Royal Sussex County Hospital
Information provided by:	Royal Sussex County Hospital
ClinicalTrials.gov Identifier:	NCT00351260

Purpose

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

Condition	Intervention	Phase
Ischaemic Heart Diseases Stenosis Angina	Procedure: Coronary Angioplasty	Phase III

MedlinePlus related topics: Angioplasty Heart Diseases

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Official Title:	British Bifurcation Coronary Study - Old, New and Evolving Strategies.

Further study details as provided by Royal Sussex County Hospital:

Primary Outcome Measures:

Death
Myocardial infarction
Target vessel revascularisation

Secondary Outcome Measures:

Repeat angiography
Stent thrombosis

Enrollment:	500
Study Start Date:	January 2005
Study Completion Date:	December 2007
Primary Completion Date:	December 2007 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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%

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00351260

Locations

United Kingdom
Royal Sussex County Hospital
Brighton, United Kingdom, BN2 5BE

Sponsors and Collaborators

Royal Sussex County Hospital

Investigators

Principal Investigator:

David J.R, Hildick-Smith, MD

Royal Sussex County Hospital

More Information

Study ID Numbers:	COREC2006
Study First Received:	July 11, 2006
Last Updated:	April 15, 2008
ClinicalTrials.gov Identifier:	NCT00351260
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by Royal Sussex County Hospital:

Bifurcation
Coronary
Stenosis
Stent
drug elution

Study placed in the following topic categories:

Heart Diseases
Myocardial Ischemia
Vascular Diseases

Angina Pectoris
Constriction, Pathologic
Ischemia

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009