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| [ ...Back to search results ] | [ Print-friendly version ] |
| Nordic-Baltic-British left main revascularisation study |
| ISRCTN | ISRCTN87206264 |
| ClinicalTrials.gov identifier | |
| Public title | Nordic-Baltic-British left main revascularisation study |
| Scientific title | Nordic-Baltic-British left main revascularisation study: coronary artery bypass grafting versus drug eluting stent percuataneous coronary angioplasty in the treatment of unprotected left main stenosis |
| Acronym | NOBLE Study |
| Serial number at source | 8342 |
| 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. |
| Lay summary | |
| Ethics approval | Brighton East REC approved on the 2nd April 2009 (ref: 09/H1107/08) |
| Study design | Multicentre randomised interventional treatment trial |
| Countries of recruitment | Denmark, Finland, Norway, Sweden, United Kingdom |
| Disease/condition/study domain | Topic: Cardiovascular; Subtopic: Cardiovascular (all Subtopics); Disease: Cardiovascular |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 19/01/2009 |
| Anticipated end date | 01/10/2010 |
| Status of trial | Completed |
| Patient information material | Not available in web format, please use the contact details provided in the interventions field below to request a patient information sheet |
| Target number of participants | Planned sample size: 1200; UK sample size: 200 |
| Interventions |
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 |
| Primary outcome measure(s) |
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 measure(s) |
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 |
| Sources of funding | Biosensors Europe SA (BESA) (Switzerland) |
| Trial website | |
| Publications | |
| Contact name | Ms Nina Cooter |
| Address |
Brighton and Sussex University Hospitals NHS Trust
Eastern Road |
| City/town | Brighton |
| Zip/Postcode | BN2 5BE |
| Country | United Kingdom |
| nina.cooter@bsuh.nhs.uk | |
| Sponsor | Brighton and Sussex University Hospitals NHS Trust (UK) |
| Address |
Royal Sussex County Hospital
Eastern Road |
| City/town | Brighton |
| Zip/Postcode | BN2 5BE |
| Country | United Kingdom |
| Sponsor website: | http://www.bsuh.nhs.uk/home/ |
| Date applied | 21/05/2010 |
| Last edited | 25/05/2010 |
| Date ISRCTN assigned | 21/05/2010 |
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