Multivessel TALENT
Research type
Research Study
Full title
A randomized controlled trial to compare the safety and efficacy of sirolimus-eluting biodegradable polymer ultra-thin stent (SUPRAFLEX™ Cruz) and everolimus-eluting biodegradable polymer stent (SYNERGY™) in treatment for three-vessel coronary artery disease: Multivessel TALENT.
IRAS ID
290834
Contact name
Azfar Zaman
Contact email
Sponsor organisation
National University of Ireland, Galway
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 3 months, 1 days
Research summary
The objective of the Multivessel TALENT study is to compare the new generation SUPRAFLEX™ Cruz ultra-thin sirolimus-eluting biodegradeable stent and the SYNERGY™ everolimus-eluting biodegradeable stent in subjects with new cardiac disease involving three main vessels of the heart. A stent is a metallic scaffold that has an external, outer layer made up of a polymer containing a drug (either sirolimus or everolimus) that is 'washed out' or eluted over time. The stent is expanded and 'plastered' against the blood vessel wall to keep it open and as the polymer gradually breaks down over several months so the bare metal scaffold, or stent, is left supporting the artery.
Both stents used in this study are commercially available and CE marked for use in Percutaneous Corononary Intervention (PCI), the procedure by which the stent is inserted into the coronary artery.
The SUPRAFLEX™ Cruz stent has an ultra-thin strut and, compared to other commercially available stents, has the thinnest strut to date. This, and the sirolimus polymer coating that disappears after 9 months may diminish potential concerns retarding vessel healing, late (and very late) thrombosis or blockage of the artery and hypersensitivity. This trial is designed around the five principles of 'best practice' PCI; taking the most current knowledge around treatment of 3 vessel disease and applying it in this study to see if SUPRAFLEX™ Cruz is as good, or better than, SYNERGY™ stents after 12 months specifically in regard to heart problems, stroke, and blockages involving the vessel that had the stent inserted at the start of the study. This study will also review the data at 2 years to determine if the SUPRAFLEX™ Cruz stent is better in respect of the procedure having to be carried out on the same lesion as that treated at the start of the study.REC name
London - Harrow Research Ethics Committee
REC reference
20/LO/1234
Date of REC Opinion
12 Feb 2021
REC opinion
Further Information Favourable Opinion