The British Bifurcation Coronary Study: Old, New and evolving strategies - A randomised comparison of simple versus complex drug-eluting stenting for bifurcation lesions

ISRCTN ISRCTN84465237
DOI https://doi.org/10.1186/ISRCTN84465237
ClinicalTrials.gov number NCT00351260
Secondary identifying numbers N0051154079
Submission date
29/09/2006
Registration date
29/09/2006
Last edited
17/03/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr David Hildick-Smith
Scientific

Brighton & Sussex University Hospitals NHS Trust (RSCH)
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesWhen 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedCoronary disease
InterventionRandomised 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 typeOther
Primary outcome measureThe primary end point will be a composite of death, myocardial infarction or target vessel failure at nine months
Secondary outcome measuresAdded 17/03/10:
1. Repeat angiography
2. Stent thrombosis
Overall study start date01/10/2004
Completion date30/09/2006

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants500
Key inclusion criteriaMen and women over 18 presenting with coronary bifurcation lesions > 2.5mm main vessel and 2.25mm side branch.
Key exclusion criteriaAdded 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%
Date of first enrolment01/10/2004
Date of final enrolment30/09/2006

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Brighton & Sussex University Hospitals NHS Trust (RSCH)
Brighton
BN2 5BE
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Brighton and Sussex University Hospitals NHS Trust (UK)

No information available

NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 16/03/2010 Yes No