TRANSFORMII: Sirolimus-coated balloon versus drug-eluting stent in native coronary vessels
Fondazione Ricerca e Innovazione Cardiovascolare ETS
Duration of Study in the UK
7 years, 0 months, 28 days
This study is international, multicentric, prospective, investigator-driven, open-label, randomized (1:1) clinical trial that observe and evaluate the efficacy, of Magic Touch SCB compared to one of the gold standard treatment for native vessel disease (everolimus-eluting stent, EES).
Both devices have CE marking certificates and meet European Union rules and regulations. They are both used for the treatment of narrowing in coronary arteries, in accord with current local clinical practice. This study will be carried out in order to verify that the Magic Touch SCB is at least as good as the everolimus-eluting DES (EES). The primary objective of the study is to verify the non-inferiority of Magic Touch SCB compared to everolimus-eluting DES (EES) in terms of TLF, a composite clinical endpoint, at 12 months.
North West - Liverpool Central Research Ethics Committee
Date of REC Opinion
7 Oct 2022
Further Information Favourable Opinion