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.

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Coronary Artery Disease
Heart Diseases
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Coronary Disease
Vascular Diseases

ClinicalTrials.gov processed this record on October 20, 2014