Transform I Randomized Clinical Trial
Research type
Research Study
Full title
Magic Touch sirolimus coated balloon (Concept Medical) versus SeQuent Please Neo paclitaxel coated balloon (B Braun) for the treatment of de novo coronary artery lesions in small vessels.
IRAS ID
263809
Contact name
Sandeep Basavarajaiah
Contact email
Sponsor organisation
Concept Medical B.V.
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 6 months, 1 days
Research summary
The study is a prospective, multinational (Italy and UK), multicenter, randomised Clinical Trial that compares the efficacy and performance of two drug coated balloon (DCB), the MAGIC TOUCH sirolimus coated balloon (Concept Medical) and SeQuent Please paclitaxel coated balloon (B Braun). The drug will be released from the DCB in a short period of time and will be retained in the vessel to reduce the chance of the blood vessel narrowing again.
Both devices have CE marking certificate and meet European Union rules and regulations. They are both used for the treatment of narrowing in coronary arteries, in accord to current local clinical practice. This study will be carried out in order to prove that the MAGIC TOUCH™ balloon is at least as good as the SeQuent™ balloon.
The objective of the study is to compare angiographic outcomes of Magic TouchTM sirolimus coated bal-loon (Concept Medical) versus SeQuentTM paclitaxel coated balloon (Bbraun) for the treatment of de no-vo coronary artery lesions in small vessels (≤2.5 mm) with respect to Net Gain (mm) at 6 months follow-up.
REC name
West Midlands - Black Country Research Ethics Committee
REC reference
19/WM/0357
Date of REC Opinion
15 Jan 2020
REC opinion
Further Information Favourable Opinion