Additional identifiers
EudraCT number
ClinicalTrials.gov number
NCT00351260
Protocol/serial number
N0051154079
Study information
Scientific title
Acronym
Study hypothesis
When treating a bifurcation coronary artery lesion is it best to treat the main vessel only, or to stent both the main vessel and the side branch?
Please note that as of 17/03/10 this trial has been updated to include exclusion criteria and secondary outcomes. All updates can be found in the relevant field with the above update date.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Coronary disease
Intervention
Randomised trial comparing stents either in a simple strategy (provisional T stenting) or a complex strategy (total lesion coverage) and to compare outcomes at nine months
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
The primary end point will be a composite of death, myocardial infarction or target vessel failure at nine months
Secondary outcome measures
Added 17/03/10:
1. Repeat angiography
2. Stent thrombosis
Overall trial start date
01/10/2004
Overall trial end date
30/09/2006
Reason abandoned
Eligibility
Participant inclusion criteria
Men and women over 18 presenting with coronary bifurcation lesions > 2.5mm main vessel and 2.25mm side branch.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
500
Participant exclusion criteria
Added 17/03/10:
1. Cardiogenic Shock
2. Acute Myocardial Infarction (MI)
3. Additional type C lesion for Rx platelets <50
4. Left Ventricular Ejection Fraction LVEF <20%
Recruitment start date
01/10/2004
Recruitment end date
30/09/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Brighton & Sussex University Hospitals NHS Trust (RSCH)
Brighton
BN2 5BE
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Brighton and Sussex University Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20194880
Publication citations
-
Results
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, 121, 10, 1235-1243, doi: 10.1161/CIRCULATIONAHA.109.888297.