Concept Medical’s SirPAD Trial of MagicTouch PTA Device Completes Enrollment

January 20, 2025—Concept Medical Inc. announced the completion of patient enrollment in the SirPAD trial of the company’s MagicTouch percutaneous transluminal angioplasty (PTA) sirolimus-coated balloon in the treatment of peripheral artery disease (PAD).

The randomized controlled SirPAD trial is evaluating major adverse limb events in patients with femoropopliteal and below-the-knee PAD treated with either the MagicTouch PTA device or an uncoated balloon (plain old balloon angioplasty; POBA).

According to the company, the trial has enrolled > 1,250 patients. Patients will be followed up at 12 months to assess the primary outcome of major adverse limb events. Final results are expected by Q1 to Q2 2026.

The company advised that the investigator-initiated, multicenter, randomized, open-label SirPAD trial aims to determine whether the MagicTouch PTA sirolimus-coated balloon is noninferior to POBA. The trial will also explore the potential for superiority.

The Principal Investigators of the study are Professor Nils Kucher, MD, and Professor Stefano Barco, MD, with the University Hospital Zurich in Zurich, Switzerland.

“Sirolimus-coated balloons represent a promising technology in treating symptomatic PAD, supported by evidence primarily from studies with surrogate endpoints,” commented Professors Kucher and Barco in the company’s press release. “While trials like SIRONA and ongoing studies such as SirPAD are expanding knowledge, robust data from randomized controlled trials with clinical outcomes are needed to guide treatment and shape future guidelines.”

They continued, “This result, having been able to randomize 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.”