TALENT-AC
Research type
Research Study
Full title
A prospective, multi-centre, randomized, post market all-comer trial to assess the safety and effectiveness of the SUPRAFLEX sirolimus-eluting coronary stent system for the treatment of atherosclerotic lesions(s).
IRAS ID
212982
Contact name
Azfar Zaman
Contact email
Sponsor organisation
European Cardiovascular Research Institute
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 0 months, 1 days
Research summary
The aim of this study is to determine if the Supraflex stent or the Xience stent is better in reducing patient death caused by heart problems (cardiac death) and/or reducing the incidence of re-blockage of the blood vessel that was stented. A stent is a metallic scaffold that is expanded and 'plastered' against the blood vessel wall to keep it open. The SUPRAFLEX stent has biodegradable parts that, over a period of 9-12 months break down leaving just the bare metal scaffold of the stent. The XIENCE family of stents has a permanent polymer coating that covers the metal scaffold and which does not break down over time. This study will recruit patients who are at least 18 years old and who have at least one coronary artery stenosis that is at least 50% blocked. These patients will be able to provide informed consent and will be willing to participate in the study for a total of 3 years follow up. The patients must be able to tolerate the drugs or stents they will receive. The patients must not have had surgical treatment for coronary artery stenosis within 6 months of this procedure and must be free of any other condition with a life expectancy of less than 12 months. The patient must be willing to return in person to the outpatient clinic for follow up visits at 1 month and 12 months and not be participating in a study that has not yet reached its primary endpoint.
REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
16/YH/0465
Date of REC Opinion
29 Nov 2016
REC opinion
Further Information Favourable Opinion