MagicTouch Balloon Vs Drug-Eluting Stent: Global Trial Hits Major Milestone With Full Patient Enrollment

The trial has now enrolled 1,832 patients across 52 centres spanning Europe, Asia, and South America.

The TRANSFORM II trial holds promise for changing the standard of care in interventional cardiology.

Source : gpointstudio/Freepik

Fondazione Ricerca e Innovazione Cardiovascolare, the Lodi, Italy-based research foundation, has announced the successful completion of patient enrollment in the TRANSFORM II randomised controlled trial (RCT). The global study, led by Dr Bernardo Cortese, aims to evaluate the safety and effectiveness of the MagicTouch Sirolimus-Coated Balloon (SCB) in comparison with the widely used everolimus-eluting stent (EES) in patients with de-novo coronary artery disease.

The trial has now enrolled 1,832 patients across 52 centres spanning Europe, Asia, and South America. The final patient was enrolled on June 6, 2025, capping off a three-and-a-half-year effort that may influence future treatment pathways for coronary artery disease.

A Landmark Global Study For Coronary Intervention

Billed as one of the largest randomised controlled trials of its kind, TRANSFORM II explores a less invasive alternative to traditional stenting. While drug-eluting stents remain the current standard for small vessel treatment, they can be suboptimal when implanted in narrow arteries. The MagicTouch SCB, on the other hand, delivers medication directly to the artery wall without leaving behind a permanent implant.

“After 3 and a half years we were able to complete the enrollment in TRANSFORM II trial, a study that involved 52 centers across 3 continents and this is amazing,” said Prof. Cortese, Chairman of the study. “Our goal is to advance the adoption of DCB in the coronary space, testing this sirolimus DCB with the most studied and used DES, in a daily patient population.”

Patients enrolled in the study had de-novo lesions in coronary arteries with diameters between 2.0 mm and 3.5 mm, and lesion lengths of up to 50 mm. The trial’s primary endpoint is Target Lesion Failure at 12 months, with patient follow-up set to continue for up to five years. A sub-study using Optical Coherence Tomography (OCT) will assess detailed angiographic results at nine months in a subset of 70 patients.

Aiming for a Paradigm Shift in Cardiac Care

The TRANSFORM II trial holds promise for changing the standard of care in interventional cardiology. Traditional stents, while effective, can sometimes “cage” small arteries and potentially compromise long-term outcomes. The SCB, by avoiding permanent implants, could offer a safer and equally effective option.

“Along with the guidance of the recently published DCB ARC guidelines, we are paving the route for the modern angioplasty era!” Prof. Cortese added.

The head-to-head comparison between MagicTouch SCB and EES will be critical in determining whether drug-coated balloon technology can be widely adopted for primary treatment of small coronary lesions — a clinical scenario representing roughly 80% of all percutaneous coronary interventions.

Industry Backs Clinical Innovation

Dr. Manish Doshi, Founder and Managing Director of Concept Medical Group — the manufacturer behind the MagicTouch SCB — called the enrollment milestone a testament to global collaboration and scientific pursuit.

“The completion of patient enrollment in TRANSFORM II is a significant milestone in our mission to bring innovative drug-delivery technologies to the forefront of interventional cardiology,” said Dr. Doshi. “We are proud to scientifically support one of the largest global randomised trials evaluating sirolimus-coated balloon technology.”

As the world awaits the 12-month outcome data, which could be pivotal in validating this novel approach, the spotlight is now firmly on whether sirolimus-coated balloons can deliver long-term benefits without the limitations of permanent stents.

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