Pioneering study: 1,832 patients for transform II inscribed!

Pioneering study: 1,832 patients for transform II inscribed!

Mailand, Italien - On June 14, 2025, Dr. Bernardo Cortese the successful completion of the patient registration for the transform II study, which is a significant milestone of progress in cardiac medicine. This study sponsored by the fondazione ricerca e innovazione cardiovascolare in Milan examines the security and effectiveness of the Sirolimus-coated balloons (SCB) Magicttouch compared to an everolimus-free stent (EES) in patients with De-Novo coronary vessels.

The study is one of the largest randomized, controlled studies that have previously been carried out to evaluate medication -coated balloons. In a total of 52 centers in Europe, Asia and South America, a patient population of 1,832 people with de-Novo lesions was included in coronary arteries. The last patient was included in the study on June 6, 2025. The main goal of this study is to evaluate the failure of the targetsion after 12 months, with a non-subdue design being pursued.

goals and methodology of the study

Transform II follows the comparative analysis between the Magictouch SCB and the EES. Patients over the age of 18 who are 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. It is expected to be monitored for up to 60 months to assess the long -term results of the treatment.

A special focus is on a sub -study on optical coherence tomography (OCT), in which 70 patients are examined after nine months in order to assess the angiographic results in a standstill. This comprehensive methodology is intended to provide decisive references to alternative treatment options for coronary heart disease.

technological background

The Magicttouch SCB uses the innovative nanoluté technology to target Sirolimus particles that should have a direct impact on the vascular walls. This technology could represent a promising alternative to the first generation of medication -coated balloons that release Paclitaxel. Reports by Concept Medical Inc. , the developer of this technology, emphasize that the use of sirolimus as an immunosuppressant prevents cell growth and thus minimizes the narrowing of the vessels without having to remain an object in the body.

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

The conclusion of the patient declaration for the transform II study not only represents significant progress in clinical research, but also illustrates the progress in the development of less invasive treatment methods to combat heart diseases.