SIRPAD – WORLD’S LARGEST RCT INVESTIGATING MAGICTOUCH PTA SIROLIMUS COATED BALLOON COMPLETES PATIENT ENROLMENT | PR Newswire [Video]

, /PRNewswire/ — Concept Medical Inc. (CMI), a global leader in innovative drug-delivery technology across vascular interventions, proudly announces the successful completion of patient enrolment in the SirPAD Trial, with over 1,250 patients now enrolled.

The SirPAD (Major adverse limb events in patients with femoro-popliteal and below-the-knee peripheral arterial disease treated with either sirolimus-coated or uncoated balloon) randomised controlled trial is the world’s largest study evaluating the treatment of Peripheral Artery Disease (PAD) using the MagicTouch PTA Sirolimus Coated Balloon (Concept Medical Inc.) versus uncoated balloons and one of the largest device studies ever performed for PAD.

More than 1,250 patients have been enrolled and will be followed up at 12 months to assess the primary outcome of major adverse limb events (MALE). Final results are expected by Q1-Q2 2026.

SirPAD is an investigator-initiated, multi-centre, randomized, open-label trial that aims to determine whether the MagicTouch PTA sirolimus-coated balloon is non-inferior to plain old balloon angioplasty (POBA). …