Nordic-Baltic-British left main revascularisation study
| ISRCTN | ISRCTN87206264 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87206264 |
| Secondary identifying numbers | 8342 |
- Submission date
- 21/05/2010
- Registration date
- 21/05/2010
- Last edited
- 21/07/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English Summary
Not provided at time of registration
Contact information
Ms Nina Cooter
Scientific
Scientific
Brighton and Sussex University Hospitals NHS Trust
Eastern Road
Brighton
BN2 5BE
United Kingdom
| nina.cooter@bsuh.nhs.uk |
Study information
| Study design | Multicentre randomised interventional treatment trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details provided in the interventions field below to request a patient information sheet |
| Scientific title | Nordic-Baltic-British left main revascularisation study: coronary artery bypass grafting versus drug eluting stent percutaneous coronary angioplasty in the treatment of unprotected left main stenosis |
| Study acronym | NOBLE Study |
| Study hypothesis | The purpose of the study is to find the most effective treatment for unprotected left main stenosis (UPLM) disease. The patients will be randomised after the diagnostic angiogram and when both the cardiac surgeons and interventional cardiologists have agreed the patient is suitable for either treatment group. Patients will be randomised on a 1:1 basis. A registry of all UPLM patients and reasons for inclusion and exclusion will be also documented during the study. The theory behind the study is that stenting of the left main stem may be of equal efficacy and safety to the current gold standard treatment, which is coronary artery bypass surgery. Coronary artery bypass surgery carries significant periprocedural morbidities so if it is proved that stenting is equivalent or superior, this would represent a good option for patients. |
| Ethics approval(s) | Brighton East REC approved on the 2nd April 2009 (ref: 09/H1107/08) |
| Condition | Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular |
| Intervention | 1. Coronary artery bypass surgery 2. Percutaneous coronary angioplasty with drug eluting stent Follow up length: 60 months Study entry: single randomisation only Contact details for patient information sheet: Cardiac Research Unit Sussex House 1 Abbey Road Brighton BN2 1ES United Kingdom |
| Intervention type | Other |
| Primary outcome measure | 1. Combined endpoint of death, stroke, non-index treatment related myocardioal infarction (MI) and new revascularisation (PCI or CABG) after 2 years 2. Death after 5 years |
| Secondary outcome measures | 1. Combined endpoint of death, stroke and non-index treatment related MI after 1 month and after 1, 2, 3 and 4 years 2. Individual endpoints of death, stroke and non-index treatment related MI after 1 month and after 1, 2, 3, 4 and 5 years 3. New revascularisation by CABG or PCI after 1, 2, 3, 4 and 5 years 4. Death after 10 years 5. Definite stent thrombosis/symptomatic graft occlusion 6. Canadian Cardiovascular Society (CCS) angina score 7. New York Heart Association (NYHA) functional class 8. Duration of admission for index treatment |
| Overall study start date | 19/01/2009 |
| Overall study end date | 01/10/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Planned sample size: 1200; UK sample size: 200 |
| Participant inclusion criteria | 1. Stable, unstable angina pectoris or acute coronary syndrome (ACS) 2. Significant lesion* of left main coronary artery (LMCA) ostium, mid-shaft and/or bifurcation and with no more than three additional non-complex** percutaneous coronary intervention (PCI) lesions 3. Patient eligible to be treated by coronary artery bypass graft (CABG) and by PCI 4. Signed informed consent *Visually assessed diameter stenosis greater than 50% or fractional flow reserve less than 0.80 **Length less than 25 mm, non-CTO, non-2-stent bifurcation, non-calcified and non-tortuous vessel morphology coronary lesion |
| Participant exclusion criteria | 1. ST-elevation infarction within 24 hours 2. CABG clearly better treatment option (LMCA stenosis and greater than 3, or complex** additional coronary lesions) 3. Patient is in too high risk for CABG 4. Expected survival less than 1 year 5. Allergy to aspirin, clopidogrel or ticlopidine 6. Allergy to Biolimus **Length greater than 25 mm, CTO, 2-stent bifurcation, calcified or tortuous vessel morphology coronary lesion |
| Recruitment start date | 19/01/2009 |
| Recruitment end date | 01/10/2010 |
Locations
Countries of recruitment
- Denmark
- England
- Finland
- Norway
- Sweden
- United Kingdom
Study participating centre
Brighton and Sussex University Hospitals NHS Trust
Brighton
BN2 5BE
United Kingdom
BN2 5BE
United Kingdom
Sponsor information
Brighton and Sussex University Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
England
United Kingdom
| Website | http://www.bsuh.nhs.uk/home/ |
|---|
Funders
Funder type
Industry
Biosensors Europe SA (BESA) (Switzerland)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
21/07/2016: No publications found, verifying study status with principal investigator
