Concept Medical Inc. (CMI), a global leader in innovative drug-delivery technology across vascular interventions, has announced the presentation of the world’s largest randomised controlled trial of a Sirolimus-Coated Balloon (SCB) for Peripheral Artery Disease (SirPAD) at the ACC 2026 Scientific Sessions.
The SirPAD trial results were presented as a Late Breaking Clinical Presentation by Prof. Dr. Stefano Barco from the University Hospital Zurich on behalf of SirPAD Steering Committee members and investigators. The findings have also been simultaneously published in the New England Journal of Medicine.
The investigator-led SirPAD trial enrolled 1,252 patients with femoropopliteal or below-the-knee PAD who were randomized to receive either the Sirolimus-Coated Balloon (SCB) MagicTouch PTA or any uncoated balloon angioplasty.
At one year, the primary endpoint of Major Adverse Limb Events (MALE), including major unplanned amputations or Target-Lesion Revascularization for critical ischemia, occurred in 8.8% of patients treated with MagicTouch PTA compared to 15% in the uncoated balloon group. This translated to a significant risk reduction, demonstrating both non-inferiority and superiority of the sirolimus-coated balloon.
Additionally, the study reported a statistically significant reduction in key secondary endpoints, including unplanned target-limb amputations and revascularizations.
“This is one of the few trials in this space to include a true all-comers population, with nearly 50% of patients presenting acute or chronic limb-threatening ischemia. This design enabled robust clinical outcomes and sufficient statistical power to demonstrate superiority at one year.” said Principal Investigators Prof. Dr. med. Nils Kucher & Prof. Dr. med. Stefano Barco, Co-Chairs of the trial.
The SirPAD trial marks a significant milestone in vascular intervention, positioning MagicTouch PTA as a promising future alternative for Peripheral Artery Disease (PAD) treatment. It also adds to a growing body of evidence supporting Sirolimus-Coated Balloon (SCB) technology across both coronary and peripheral applications.
Supporting these findings, the SIRONA randomized controlled trial in femoropopliteal Peripheral Artery Disease (PAD) has already demonstrated the non-inferiority of MagicTouch PTA compared to paclitaxel drug-coated balloons.
With the publication of SirPAD’s primary results, the study provides strong clinical evidence that sirolimus-coated balloons can improve outcomes in a broad patient population. These findings are expected to influence future treatment guidelines and expand therapeutic options for physicians.
“SirPAD represents a major milestone for the PAD community and the evolution of sirolimus-coated balloon therapy. The validation of MagicTouch PTA through a large, investigator-led randomized trial and peer-reviewed publication underscores our commitment to evidence-based innovation.” said Dr Manish Doshi, Founder & Managing Director of Concept Medical & Inventor of MagicTouch.