PRNewswire

Cleveland (Ohio) [US], June 13: Primary Investigator, Bernardo Cortese MD, proudly announces the successful completion of patient enrollment in the TRANSFORM II randomized controlled trial (RCT). This pivotal study aims to evaluate the safety and efficacy of the MagicTouch Sirolimus-Coated Balloon (SCB) compared to an everolimus-eluting stent (EES) in treating de-novo coronary vessels.

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TRANSFORM II (Sirolimus-Coated Balloon Versus Drug-Eluting Stent in Native Coronary Vessels) is an investigator-driven trial sponsored by Fondazione Ricerca e Innovazione Cardiovascolare in Milano, Italy, and has now achieved its target enrollment of >1,820 patients. The final patient was enrolled on 6th June 2025, marking a major milestone for the trial. Led by Study Chairman Prof. Bernardo Cortese (University Hospitals Harrington Heart & Vascular Institute, Cleveland, USA) and a distinguished steering committee, TRANSFORM II is one of the largest global randomized controlled trials evaluating drug-coated balloon and has enrolled patients from 52 centers across Europe, Asia and South America. Key features of the TRANSFORM II trial include:

* Comparative Arms: MagicTouch SCB vs. Everolimus-Eluting Stent (EES)

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* Patient Population: 1,832 patients with de-novo lesions in coronary arteries (vessel diameter >2.0 mm to

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