#USA #Cleveland #Concept Medical #MagicTouch SCB #TRANSFORM II

Transformative Step in Cardiology: Enrollment Completion of TRANSFORM II Trial

In a significant development for the field of interventional cardiology, the completion of patient enrollment in the TRANSFORM II randomized controlled trial (RCT) has been officially announced. Spearheaded by Dr. Bernardo Cortese from the University Hospitals Harrington Heart and Vascular Institute, this landmark study aims to evaluate the comparative effectiveness of the MagicTouch Sirolimus-Coated Balloon (SCB) against the everolimus-eluting stent (EES) in treating de-novo coronary vessels.

After an intensive enrollment period over three and a half years, the study proudly reaches its goal, involving over 1,820 patients across 52 centers worldwide spanning Europe, Asia, and South America. The final enrollment was completed on June 6, 2025, marking a significant milestone in this pivotal evaluation of two distinct approaches in managing coronary artery disease.

Key Features of the TRANSFORM II Trial

TRANSFORM II is meticulously designed to determine essential outcomes regarding the safety and efficacy of the MagicTouch SCB. The trial includes:

• - Comparative Arms: Study efficacy between MagicTouch SCB vs. Everolimus-Eluting Stent (EES)
• - Patient Population: A diverse group of 1,832 individuals with de-novo lesions in coronary arteries, specifically targeting those with vessel diameters ranging from >2.0 mm to ≤3.5 mm and lesion lengths not exceeding 50 mm.
• - Primary Endpoint: Investigating Target Lesion Failure at the 12-month mark, structured under a non-inferiority design.
• - Extended Follow-Up: Participants will be monitored for a duration of up to 60 months (five years) following their enrollment.
• - Sub-Study: Optical Coherence Tomography (OCT) imaging is planned for 70 patients at the nine-month point to further assess the angiographic outcomes.

The Ambition Behind TRANSFORM II

In his remarks, Dr. Cortese emphasized the collaborative efforts of the team at Fondazione Ricerca e Innovazione Cardiovascolare, paying tribute to the dedication that allowed such a voluminous patient enrollment in a study of this magnitude. Dr. Cortese stated, “Our goal is to advance the adoption of drug-coated balloons in the coronary space, testing our sirolimus DCB against the most extensively studied and utilized stent in daily practice.” This indicates a hampered need to pave the way for a modern angioplasty era, enabling interventional cardiologists to pivot towards more patient-centric strategies that could significantly enhance long-term outcomes.

Challenges with Current Treatments

Coronary vessels of this size constitute approximately 80% of patients undergoing percutaneous coronary interventions, presenting unique challenges in treatment options. Currently, interventional cardiologists frequently rely on permanent implants in the form of drug-eluting stents (DES), which could restrict vessel function and potentially compromise long-term patient outcomes. The TRANSFORM II trial seeks to explore the possibilities surrounding drug-coated balloons as a more favorable alternative for such scenarios.

Innovation in Drug-Coated Balloons Tech

With a history of encouraging data, drug-coated balloon technology has emerged as a promising solution for small, de-novo coronary lesions. The MagicTouch SCB, which utilizes the innovative Nanoluté technology developed by Concept Medical Inc., has shown its potential in delivering sirolimus effectively, promoting deep vessel wall penetration.

“Completing patient enrollment in TRANSFORM II is a landmark achievement,” stated Dr. Manish Doshi, the founder and managing director of Concept Medical Group. He emphasized the company's objective to elevate the standards of interventional cardiology through innovative research and the development of drug-delivery technologies.

As the TRANSFORM II trial advances, it is poised to generate significant data that may not only validate the efficacy of SCB technology but also encourage its broader adoption, ushering in a new paradigm in cardiac interventions. The initial 12-month outcomes will shed light on the potential long-term benefits of avoiding permanent stent implants in the treatment of patients afflicted with coronary artery disease.