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BBC ONE - British Bifurcation Coronary Study (BBC ONE)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00351260
First Posted: July 12, 2006
Last Update Posted: April 16, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Royal Sussex County Hospital
  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 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00351260     History of Changes
Other Study ID Numbers: COREC2006
First Submitted: July 11, 2006
First Posted: July 12, 2006
Last Update Posted: April 16, 2008
Last Verified: March 2008

Keywords provided by Royal Sussex County Hospital:
Bifurcation
Coronary
Stenosis
Stent
drug elution

Additional relevant MeSH terms:
Heart Diseases
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases