SELUTION ISR IDE - SEL-003-2019
Research type
Research Study
Full title
SELUTION SLR™ 014 ISR: A Prospective Randomized Single Blind Multicenter Study to Assess the Safety and Effectiveness of the SELUTION SLR™ 014 Drug Eluting Balloon in the Treatment of Subjects with In-stent Restenosis
IRAS ID
274848
Contact name
Iain Anthony
Contact email
Sponsor organisation
MedAlliance LLC
Clinicaltrials.gov Identifier
Duration of Study in the UK
6 years, 2 months, 30 days
Research summary
This study will evaluate the MedAlliciance SELUTION SLR™ drug eluting balloon in patients with a stent placed in one of the coronary arteries and now have developed a narrowing (re-stenosis) inside of the stent. The purpose of this study is to evaluate whether the SELUTION SLR™ drug eluting balloon is safe and that it works effectively for patients with in-stent restenosis of coronary arteries. During the procedure the patient will be treated with a SELUTION SLR™ drug eluting balloon or according to standard care (a standard non-drug coated balloon or standard Drug Eluting Stent). The patient will be blinded to the treatment given after randomization and will remain blinded until they reach primary endpoint at 12 months. After the procedure, patients will be followed-up by the doctor at 1 month, 6 months, 12 months, 2 years, 3 years, 4 years and 5 years. In total up to 60 centers will participate across Europe and the US to enrol a total of 418 patients.
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
21/EE/0035
Date of REC Opinion
20 Apr 2021
REC opinion
Further Information Favourable Opinion