Groundbreaking study: 1,832 patients enrolled in TRANSFORM II!

Groundbreaking study: 1,832 patients enrolled in TRANSFORM II!

On June 14, 2025, Dr. Bernardo Cortese successfully completed patient registration for the TRANSFORM II study, which represents a significant milestone in cardiac medicine. This one from the Fondazione Ricerca e Innovazione Cardiovascolare Milan-sponsored study examines the safety and effectiveness of the sirolimus-coated balloon (SCB) MagicTouch compared to an everolimus-eluting stent (EES) in patients with de novo coronary artery disease.

The study is one of the largest randomized, controlled trials ever conducted to evaluate drug-coated balloons. A patient population of 1,832 people with de novo lesions in coronary arteries were included in a total of 52 centers in Europe, Asia and South America. The last patient was enrolled on June 6, 2025. The primary objective of this study is to evaluate target lesion failure at 12 months using a non-inferiority design.

Objectives and methodology of the study

TRANSFORM II pursues the comparative analysis between the MagicTouch SCB and the EES. Patients over 18 years of age clinically indicated for percutaneous coronary intervention (PCI) in native vessels were selected for the study. The inclusion criteria included lesions with a diameter of more than 2.0 mm up to 3.5 mm and a maximum lesion length of 50 mm. Patients are expected to be monitored for up to 60 months to assess the long-term results of the treatment.

Particular attention is paid to a substudy on optical coherence tomography (OCT), in which 70 patients will be examined after nine months in order to meaningfully evaluate the angiographic results. This comprehensive methodology is intended to provide crucial information about alternative treatment options for coronary heart disease.

Technological background

The MagicTouch SCB uses the innovative Nanoluté technology for the targeted delivery of sirolimus particles, which are said to have a direct influence on the vessel walls. This technique could provide a promising alternative to the first generation of drug-coated balloons that deliver paclitaxel. Reports from Concept Medical Inc., the developer of this technology, emphasize that the use of sirolimus as an immunosuppressant prevents cell growth, thereby minimizing the re-narrowing of the vessels, without the need for any object to remain in the body.

In addition, in the context of current research, the challenges of producing coated balloon catheters are also pointed out. An effective coating that ensures that the drugs are quickly transferred into the artery wall is crucial for the success of the treatment. The Fraunhofer Institute for Production Engineering and Automation has developed automation solutions to sustainably increase the quality and effectiveness of these products. Innovative approaches are intended to achieve more efficient production of balloon catheters, which could also increase the acceptance of this form of therapy, as Dr. Thomas Speck from InnoRa describes in a report.

The completion of patient enrollment in the TRANSFORM II study not only represents a significant advance in clinical research, but also highlights progress in the development of less invasive treatments to combat heart disease.