UK all-comers Sirolimus-Eluting Balloon Registry: UK-SEB Registry
Research type
Research Study
Full title
UK prospective registry on sirolimus drug-coated balloon (UK all-comers Sirolimus-Eluting Balloon Registry: UK-SEB Registry)
IRAS ID
251988
Contact name
Sandeep Basavarajaiah
Contact email
Sponsor organisation
Acrostak Uk Ltd.
Duration of Study in the UK
1 years, 0 months, 1 days
Research summary
UK-SEB Registry is initiated with a purpose of evaluating the performance of a Sirolimus Coated Balloon (SCB) for the treatment of coronary stenosis, including both de novo (narrowing within the native vessel) and restenotic lesions (narrowing within the previously placed stent). The study is a prospective, multi centre, spontaneous clinical registry that will enrol real world, all comer patients at various interventional cardiology sites in England. The study targets the enrolment of 700 patients. Patients will be followed up after hospital discharge for up to 24 months: clinic visits or phone calls will be scheduled at 1, 6, 12 and 24 months. The investigational device in the study is the world’s first Sirolimus coated balloon (Magictouch) which is a CE marked. The Magictouch SCB that will be used in this study is a semi-compliant polyamide balloon-catheter with low tip profile (0.016”), coated with Sirolimus drug (drug dose of 180μg on 3.0 x 15 mm balloon, drug to excipient ratio of 1:1). Before participating, all subjects will be informed about the study and will be asked to provide a written informed consent. They will only be enrolled if they consent for the study. After enrolment, the procedure will consist of a planned coronary angioplasty as per the international guidelines or local hospital protocol. Post-procedure, they will undergo the usual formalities as per the hospital and/or local guidelines. All patients’ data will be reported on the CRF (case report form), which is an online electronic portal to enter patient’s data for the research purpose. This can be accessed only by the members of the research team and patient’s identification will be anonymised.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
19/WM/0004
Date of REC Opinion
20 Feb 2019
REC opinion
Further Information Favourable Opinion