S-FLEX UK-II, Rev 1
Research type
Research Study
Full title
Prospective Evaluation of Thin-strut Biodegradable Polymer-coated Supraflex Sirolimus-Eluting Stents in an All-comers Patient Population (S-FLEX UK-II)
IRAS ID
246372
Contact name
Azfar Zaman
Contact email
Sponsor organisation
Sahajanand Medical Technologies Pvt. Ltd (SMT)
ISRCTN Number
ISRCTN39751665
Duration of Study in the UK
1 years, 6 months, 31 days
Research summary
This study is a prospective, observational, multi centre, single-arm registry designed to evaluate the clinical safety and performance of the thin-strut (60 µm) biodegradable polymer-coated Supraflex Sirolimus-eluting stents (SES) in an all-comers patient population within daily clinical practice. The registry does not influence the choice of stent utilised in the patient treatment. This registry will collect information on patient outcomes for 3000 patients from up to 35 NHS Hospital sites in England, Wales and Scotland. Participants will only be enrolled on to the registry if informed consent has been obtained and they meet the inclusion / exclusion criteria specified in the Study Protocol. \nAll patients will be followed with telephonic follow-up at 30 days and 12 months after the index procedure. \n\nAs this study is a collection of information about the intervention and patient outcomes at 30 days and 12 months, participation in this study does not provide the participant with any greater benefit nor does it give rise to any increased risk. The study will contribute to existing knowledge of the clinical safety and performance of the 60µm SES stent. \n\nIt is anticipated that the entire duration of the project will be 18 months inclusive of enrolment, data analysis and report production. Subgroups pre-specified for data analysis includes diabetic patients, bifurcations, patients with type B2/C lesion and patients with long lesion. The study will be wholly funded by the study sponsor Sahajanand Medical Technologies.
REC name
South West - Cornwall & Plymouth Research Ethics Committee
REC reference
18/SW/0130
Date of REC Opinion
21 Jun 2018
REC opinion
Further Information Favourable Opinion