Nordic-Baltic-British left main revascularisation study

ISRCTN	ISRCTN87206264
DOI	https://doi.org/10.1186/ISRCTN87206264
Protocol serial number	8342
Sponsor	Brighton and Sussex University Hospitals NHS Trust (UK)
Funder	Biosensors Europe SA (BESA) (Switzerland)

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 of protocol

Not provided at time of registration

Contact information

Ms Nina Cooter
Scientific

Brighton and Sussex University Hospitals NHS Trust
Eastern Road
Brighton
BN2 5BE
United Kingdom

Email	nina.cooter@bsuh.nhs.uk

Study information

Primary study design	Interventional
Study design	Multicentre randomised interventional treatment trial
Secondary study design	Randomised controlled trial
Study type	Participant 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 objectives	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)
Health condition(s) or problem(s) studied	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(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
Key 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
Completion date	01/10/2010

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	1200
Key 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
Key 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
Date of first enrolment	19/01/2009
Date of final enrolment	01/10/2010

Locations

Countries of recruitment

United Kingdom
England
Denmark
Finland
Norway
Sweden

Study participating centre

Brighton and Sussex University Hospitals NHS Trust

Brighton
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?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

21/07/2016: No publications found, verifying study status with principal investigator