#Italy #Milan #MagicTouch SCB #TRANSFORM II #cardiac innovations

The TRANSFORM II Trial: A Significant Step in Cardiovascular Research

The Fondazione Ricerca e Innovazione Cardiovascolare, based in Milan, has announced a major milestone with the successful completion of patient enrollment in the TRANSFORM II trial. This landmark randomized controlled trial aims to compare the efficacy and safety of the MagicTouch sirolimus-coated balloon (SCB) against the established drug-eluting stent (DES) treatment in patients with de novo lesions in native coronary arteries.

Led by Principal Investigator Dr. Bernardo Cortese, the TRANSFORM II trial reached its target enrollment of 1,832 patients, with the last participant registered on June 6, 2025. The trial is now being conducted at 52 medical centers across Europe, Asia, and South America, making it one of the largest randomized studies assessing the impact of sirolimus-coated balloons in coronary treatment.

Key Attributes of the TRANSFORM II Study

The major features of the TRANSFORM II study include:

• - Comparative Arms: The trial compares the MagicTouch SCB with the everolimus drug-eluting stent (EES).
• - Patient Population: The study involves patients with de novo coronary lesions (artery diameter > 2.0 mm and ≤ 3.5 mm, and lesion length ≤ 50 mm).
• - Primary Endpoint: The primary endpoint is the target lesion failure at 12 months, assessed under a non-inferiority design.
• - Follow-Up: Patients will be monitored for up to five years (60 months).
• - Substudy: The trial also plans to conduct an optical coherence tomography (OCT) substudy with 70 patients at the nine-month mark to evaluate angiographic outcomes.

Dr. Cortese emphasized the successful patient enrollment, highlighting that the three-and-a-half-year endeavor was made possible due to the dedicated efforts from both the Fondazione RIC team and the investigators involved from multiple countries. This trial not only aims to advance the clinical application of drug-coated balloons in coronary intervention but also seeks to reshape the future of treatments for coronary artery disease.

The Importance of This Research

Coronary arteries that fall within the specified size range account for approximately 80% of patients undergoing percutaneous coronary interventions. Current practices often necessitate the permanent implantation of a drug-eluting stent, which can limit the long-term outcomes for patients by creating a physical obstruction within these arteries. The direct comparison of MagicTouch SCB against the standard treatment of drug-eluting stents in this trial is poised to provide decisive evidence for an alternative therapeutic approach.

Sirolimus-coated balloons have long been recognized as a promising solution for treating small de novo coronary lesions, presenting a viable alternative to the first-generation drug-coated balloon technology that utilized paclitaxel. As the TRANSFORM II trial progresses, it is anticipated that the extensive data it gathers will foster a paradigm shift towards a broader acceptance and use of drug-coated balloons in clinical settings.

Insights from Concept Medical

Dr. Manish Doshi, founder and managing director of Concept Medical Group, remarked on the successful completion of patient enrollment into the TRANSFORM II trial, noting it as a significant achievement in the journey to bring innovative drug delivery technologies to forefront of interventional cardiology. The enrollment not only exemplifies their commitment to clinical excellence but also underscores their dedication to improving patient outcomes globally.

About the MagicTouch SCB

Developed by Concept Medical Inc., based in Tampa, Florida, the MagicTouch SCB utilizes advanced Nanoluté technology to deliver submicronic sirolimus particles encapsulated in a biocompatible carrier, allowing for deep penetration into vascular walls. The device has gained CE mark approval in Europe and received FDA IDE designation for use in treating small coronary vessels and in-stent restenosis, with ongoing clinical trials to validate its effectiveness.

For more information on this groundbreaking study and its implications for the future of cardiovascular treatment, visit conceptmedical.com. As we look ahead, the initial results from the TRANSFORM II trial, expected at the 12-month follow-up, will offer valuable insights into the long-term benefits of avoiding permanent implants in coronary interventions.