Archive · 13 Jun 2025
TRANSFORM II Trial Completes Enrollment; Tests New Heart Treatment
Doctors are testing a new type of balloon called MagicTouch to help people with problems in their heart's blood vessels.
They are comparing it to a small tube called a stent that is often used.
This study, called TRANSFORM II, included over 1,820 patients.
The goal is to see if the MagicTouch balloon works as well as the stent.
They will watch the patients for up to 5 years to see how they do.
The study hopes to show if the balloon can be a good choice instead of always using a stent.
This could mean fewer long-term problems for people with heart issues.
TRANSFORM II trial successfully completed patient enrollment with over 1,820 patients.
The trial compares the MagicTouch Sirolimus-Coated Balloon (SCB) to an everolimus-eluting stent (EES).
Patients have de-novo lesions in coronary arteries with vessel diameters >2.0 mm to ≤3.5 mm and lesion lengths ≤50 mm.
The primary endpoint of the study is Target Lesion Failure at 12 months, with a non-inferiority design.
The trial will monitor patients for up to 60 months (5 years) with a sub-study using Optical Coherence Tomography (OCT) imaging.
- Who
- The trial is led by Prof. Bernardo Cortese, sponsored by Fondazione Ricerca e Innovazione Cardiovascolare, and developed by Concept Medical Inc.
- What
- TRANSFORM II trial completed patient enrollment comparing MagicTouch SCB to EES in coronary vessels.
- When
- Enrollment completed on June 6, 2025. Patients will be monitored for up to 60 months.
- Where
- The trial enrolled patients from 52 centers across Europe, Asia, and South America.
- Why
- To evaluate the safety and efficacy of the MagicTouch SCB compared to an everolimus-eluting stent (EES) for treating de-novo coronary vessels and improve patient outcomes.
Potential Benefits of SCB
Standard of Care
Treatment Approach
Potential Benefits of SCB
SCBs may offer an alternative to permanent implants.
Standard of Care
Drug-eluting stents are current standard of care for coronary lesions.
- Trial Name
- TRANSFORM II
- Objective
- Compare MagicTouch SCB vs. Everolimus-Eluting Stent (EES)
- Patient Count
- >1,820
- Primary Endpoint
- Target Lesion Failure at 12 months
- Follow-Up
- Up to 60 months
- SCB Developer
- Concept Medical Inc.