Cleveland: An Italy-based research foundation, Fondazione Ricerca e Innovazione Cardiovascolare has announced the completion of patient enrolment for a trial evaluating the safety and effectiveness of Sirolimus-Coated Balloon (SCB) in comparison with the Drug-eluting Stents.
The trial has enrolled a total of 1,832 patients from Europe, Asia, and South America and designed to evaluate the safety and effectiveness of the MagicTouch Sirolimus-Coated Balloon (SCB) in comparison with the Everolimus-Eluting Stent (EES) in patients with De-Novo Coronary Artery Disease.
“After 3 and half years, we were able to complete the enrolment in TRANSFORM II trial, a study that involved 52 centers across 3 continents and will test this Sirolimus DCB with the most studied and used DES, in a daily patient population,” said Dr Bernardo Cortese, the Study Chairman.
The head-to-head comparison is undertaken to determine whether drug-coated balloon technology can be widely adopted for primary treatment of small coronary lesions—which currently accounts for nearly 80 per cent of all Percutaneous Coronary Interventions.
Developed by Concept Medical in delivers sub-micron particles of sirolimus encapsulated in a biocompatible carrier, ensuring deep penetration into the vessel wall.
The device has obtained Breakthrough Device Designation from the US FDA for the treatment of small coronary vessels and in-stent restenosis.
