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 (NCT) | NCT00351260 |
| Protocol serial number | N0051154079 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funders | Brighton and Sussex University Hospitals NHS Trust (UK), NHS R&D Support Funding |
- 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
Scientific
Brighton & Sussex University Hospitals NHS Trust (RSCH)
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure(s) | The primary end point will be a composite of death, myocardial infarction or target vessel failure at nine months |
| Key secondary outcome measure(s) | Added 17/03/10: 1. Repeat angiography 2. Stent thrombosis |
| Completion date | 30/09/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 500 |
| Key inclusion criteria | Men and women over 18 presenting with coronary bifurcation lesions > 2.5mm main vessel and 2.25mm side branch. |
| Key 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% |
| Date of first enrolment | 01/10/2004 |
| Date of final enrolment | 30/09/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Brighton & Sussex University Hospitals NHS Trust (RSCH)
Brighton
BN2 5BE
United Kingdom
BN2 5BE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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 |
