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Time of India

Study evaluating efficacy of Sirolimus-Coated Balloon against Drug-eluting Stent completes patient enrollment

Cleveland: An Italy-based research foundation, the Lodi 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.