Concept Medical has announced the successful completion of patient enrolment in the SirPAD trial, with over 1,250 patients now enrolled.
A press release notes that the SirPAD (Major adverse limb events in patients with femoropopliteal 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 PAD using the MagicTouch PTA sirolimus-coated balloon 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, multicentre, randomised, open-label trial that aims to determine whether the MagicTouch PTA sirolimus-coated balloon is non-inferior to plain balloon angioplasty. The trial will also explore the potential for superiority.
Principal investigators Nils Kucher and Stefano Barco from the University Hospital Zurich (Zurich, Switzerland) said in a press release: “Sirolimus-coated balloons represent a promising technology in treating symptomatic PAD, supported by evidence primarily from studies with surrogate endpoints. While trials like SIRONA and ongoing studies such as SirPAD are expanding knowledge, robust data from randomised controlled trials with clinical outcomes are needed to guide treatment and shape future guidelines. This result, having been able to randomise so many patients in a PAD device study, is unprecedented and we are very thankful to all investigators and patients for having supported the trial.”
