CMI, a global leader in innovative drug delivery technologies for vascular procedures, is proud to announce that patient enrollment in the SirPAD trial has been successfully completed, with more than 1,250 patients enrolled to date.

The SirPAD randomized controlled trial (Major Limb Adverse Events in Patients With Seropolis and Subgenicular Femoropopliteal Peripheral Arterial Disease Treated with a Sirolimus or Non-Sirolimus Cuff) is the world's largest study evaluating the treatment of peripheral arterial disease (PAD) using the MagicTouch PTA Sirolimus Coated Balloon (Concept Medical Inc.) compared to uncoated cuffs, and one of the largest studies ever conducted on PAD treatment devices.

More than 1,250 patients have been enrolled and will be followed up after 12 months to assess the primary endpoint, major limb-level adverse events (MAEs). Final results are expected in the first quarter of 2026.

SirPAD is a multicenter, randomized, open-label, investigator-initiated trial to determine whether the Sirolimus-coated MagicTouch PTA Balloon is non-inferior to conventional balloon angioplasty (POBA). The trial will also explore the potential for superiority.

The principal investigators, Prof. Dr. med. Nils Kucher and Prof. Stefano Barco, from the University Hospital Zurich, who is leading this ambitious study, said: "Sirolimus-coated balloons represent a promising technology in the treatment of symptomatic PAD, supported by data mainly from studies with surrogate endpoints. While trials like SIRONA and ongoing studies like SirPAD are helping to add knowledge, robust data from randomized controlled trials with clinical outcomes are needed to guide treatment and define future guidelines. This result, the randomization of so many patients to a study of PAD treatment devices, is unprecedented and we are very grateful to all investigators and patients for supporting the trial" as the important milestone of enrolling more than 1,250 patients has been reached and this phase of the study has been successfully completed.

With sirolimus-coated balloons gaining traction globally, led by the MagicTouch PTA, SirPAD is a crucial step in enriching data on PAD treatment options. While the treatment methods available to patients with PAD are limited, SirPAD aims to strengthen the data in support of sirolimus-coated balloon technology. This large-scale randomized clinical trial was essential for evaluating substitution treatments, and its one-year follow-up will provide much-needed answers.

"At Concept Medical, we are committed to generating strong clinical data to support our innovative technologies. Following the successful completion of SIRONA – the largest superficial femoral artery (SFA) study comparing our device to paclitaxel-coated balloons (DCBs), which demonstrated non-inferiority – we are proud to announce the completion of enrollment for another historic milestone: the largest randomized clinical trial for run-of-mine MAP patients, for which more than 1,250 patients have been enrolled. With this success, Concept Medical continues to lead the way with the most comprehensive and advanced clinical trial program in this field, strengthening our position as a global pioneer in patient-centric vascular innovations," said Dr. Manish Doshi, Founder and Chief Executive Officer of Concept Medical.