FAME 3
Research type
Research Study
Full title
A Comparison of Fractional Flow Reserve-Guided Percutaneous Coronary Intervention and Coronary Artery Bypass Graft Surgery in Patients with Multivessel Coronary Artery Disease - The FAME 3 Trial
IRAS ID
157143
Contact name
Keith G Oldroyd
Contact email
Sponsor organisation
Stanford University School of Medicine
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 10 months, 1 days
Research summary
Currently, there are two different types of procedures to improve blood flow to the heart coronary artery bypass graft (CABG) surgery and the implantation of stents (small, hollow mesh-like metal tubes) in the arteries around the heart.The Medtronic Resolute Integrity drug-eluting stent (stent coated with medication) has been shown to have an advantage over earlier versions of drug-eluting stents in terms of preventing renarrowing of the stent. The Resolute Integrity stent has been approved by the U.S. Food and Drug Administration (FDA) for use in diseased heart vessels. The use of multiple Resolute stents has not been well-studied specifically in patients with multiple blockages, and is therefore considered investigational (not approved by the FDA). Because it is not known what procedure is better for patients with multi vessel disease this study will assign patients to receive one treatment or the other in a carefully controlled scientific manner, and will compare the results. The assignments to either CABG or drug-eluting stents, the collection of information about you, your procedure, resource utilisation and the results of the procedure, make up the research to be done in this study.
REC name
West of Scotland REC 1
REC reference
14/WS/1106
Date of REC Opinion
21 Oct 2014
REC opinion
Further Information Favourable Opinion