Condition category
Circulatory System
Date applied
21/05/2010
Date assigned
21/05/2010
Last edited
21/07/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Nina Cooter

ORCID ID

Contact details

Brighton and Sussex University Hospitals NHS Trust
Eastern Road
Brighton
BN2 5BE
United Kingdom
-
nina.cooter@bsuh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

8342

Study information

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

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

Brighton East REC approved on the 2nd April 2009 (ref: 09/H1107/08)

Study design

Multicentre randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details provided in the interventions field below to request a patient information sheet

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

Phase

Not Applicable

Drug names

Primary outcome measures

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 trial start date

19/01/2009

Overall trial end date

01/10/2010

Reason abandoned

Eligibility

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 type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Planned sample size: 1200; UK sample size: 200

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, Finland, Norway, Sweden, United Kingdom

Trial participating centre

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

Sponsor information

Organisation

Brighton and Sussex University Hospitals NHS Trust (UK)

Sponsor details

Royal Sussex County Hospital
Eastern Road
Brighton
BN2 5BE
United Kingdom

Sponsor type

Hospital/treatment centre

Website

http://www.bsuh.nhs.uk/home/

Funders

Funder type

Industry

Funder name

Biosensors Europe SA (BESA) (Switzerland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

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