S-FLEX UK Registry (v 1.3)
Research type
Research Study
Full title
S-FLEX UK Registry: Prospective evaluation of the Supraflex™ sirolimus-eluting coronary stent system in a "real-world" patient population.
IRAS ID
171365
Contact name
Azfar Zaman
Sponsor organisation
Sahajanand Medical Technologies Pvt. Ltd (SMT)
Duration of Study in the UK
1 years, 10 months, 14 days
Research summary
The primary objective of this registry is to evaluate the safety and efficacy of the Supraflex™ sirolimus-eluting coronary stent system in a 'real-world' patient population requiring stent implantation.This post-market registry (PMS) will be conducted on 500 patients, these patients must meet the inclusion and exclusion criteria in order to take part in the PMS. All patients will be followed clinically at 12-months after the procedure has taken place.
REC name
Wales REC 7
REC reference
15/WA/0121
Date of REC Opinion
21 May 2015
REC opinion
Further Information Favourable Opinion