BBC ONE - British Bifurcation Coronary Study

This study has been completed.
Sponsor:
Information provided by:
Royal Sussex County Hospital
ClinicalTrials.gov Identifier:
NCT00351260
First received: July 11, 2006
Last updated: April 15, 2008
Last verified: March 2008
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: British Bifurcation Coronary Study - Old, New and Evolving Strategies.

Resource links provided by NLM:


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

No publications provided by Royal Sussex County Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00351260     History of Changes
Other Study ID Numbers: COREC2006
Study First Received: July 11, 2006
Last Updated: April 15, 2008
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

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

Additional relevant MeSH terms:
Constriction, Pathologic
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Pathological Conditions, Anatomical
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on April 15, 2014