Back to resultsBBC ONE - British Bifurcation Coronary Study (BBC ONE)
Primary Purpose
Ischaemic Heart Diseases, Stenosis, Angina
Status
Completed
Phase
Phase 3
Locations
United Kingdom
Study Type
Interventional
Intervention
Coronary Angioplasty
Sponsored by
About this trial
This is an interventional treatment trial for Ischaemic Heart Diseases focused on measuring Bifurcation, Coronary, Stenosis, Stent, drug elution
Eligibility 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%
Sites / Locations
- Royal Sussex County Hospital
Outcomes
Primary Outcome Measures
Death
Myocardial infarction
Target vessel revascularisation
Secondary Outcome Measures
Repeat angiography
Stent thrombosis
Full Information
NCT ID
NCT00351260
First Posted
July 11, 2006
Last Updated
April 15, 2008
Sponsor
Royal Sussex County Hospital
1. Study Identification
Unique Protocol Identification Number
NCT00351260
Brief Title
BBC ONE - British Bifurcation Coronary Study
Acronym
BBC ONE
Official Title
British Bifurcation Coronary Study - Old, New and Evolving Strategies.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2008
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Royal Sussex County Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The study aims to assess whether a SIMPLE or a COMPLEX strategy is best for the treatment of coronary bifurcation stenoses.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischaemic Heart Diseases, Stenosis, Angina
Keywords
Bifurcation, Coronary, Stenosis, Stent, drug elution
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Coronary Angioplasty
Primary Outcome Measure Information:
Title
Death
Title
Myocardial infarction
Title
Target vessel revascularisation
Secondary Outcome Measure Information:
Title
Repeat angiography
Title
Stent thrombosis
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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%
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David J.R, Hildick-Smith, MD
Organizational Affiliation
Royal Sussex County Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Sussex County Hospital
City
Brighton
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
27161619
Citation
Behan MW, Holm NR, de Belder AJ, Cockburn J, Erglis A, Curzen NP, Niemela M, Oldroyd KG, Kervinen K, Kumsars I, Gunnes P, Stables RH, Maeng M, Ravkilde J, Jensen JS, Christiansen EH, Cooter N, Steigen TK, Vikman S, Thuesen L, Lassen JF, Hildick-Smith D. Coronary bifurcation lesions treated with simple or complex stenting: 5-year survival from patient-level pooled analysis of the Nordic Bifurcation Study and the British Bifurcation Coronary Study. Eur Heart J. 2016 Jun 21;37(24):1923-8. doi: 10.1093/eurheartj/ehw170. Epub 2016 May 8.
Results Reference
derived
PubMed Identifier
21205942
Citation
Behan MW, Holm NR, Curzen NP, Erglis A, Stables RH, de Belder AJ, Niemela M, Cooter N, Chew DP, Steigen TK, Oldroyd KG, Jensen JS, Lassen JF, Thuesen L, Hildick-Smith D. Simple or complex stenting for bifurcation coronary lesions: a patient-level pooled-analysis of the Nordic Bifurcation Study and the British Bifurcation Coronary Study. Circ Cardiovasc Interv. 2011 Feb 1;4(1):57-64. doi: 10.1161/CIRCINTERVENTIONS.110.958512. Epub 2011 Jan 4.
Results Reference
derived
PubMed Identifier
20194880
Citation
Hildick-Smith D, de Belder AJ, Cooter N, Curzen NP, Clayton TC, Oldroyd KG, Bennett L, Holmberg S, Cotton JM, Glennon PE, Thomas MR, Maccarthy PA, Baumbach A, Mulvihill NT, Henderson RA, Redwood SR, Starkey IR, Stables RH. Randomized trial of simple versus complex drug-eluting stenting for bifurcation lesions: the British Bifurcation Coronary Study: old, new, and evolving strategies. Circulation. 2010 Mar 16;121(10):1235-43. doi: 10.1161/CIRCULATIONAHA.109.888297. Epub 2010 Mar 1.
Results Reference
derived
Learn more about this trial
BBC ONE - British Bifurcation Coronary Study
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