SirPAD Clinical Trial Achieves Milestone with Patient Enrollment Completion

SirPAD Clinical Trial Achieves Milestone with Over 1,250 Enrolled Patients

On January 20, 2025, Concept Medical Inc. announced a significant achievement in the medical field with the completion of patient enrollment for the SirPAD clinical trial. This remarkable endeavor has successfully facilitated the participation of over 1,250 patients, marking it as the largest randomized controlled trial (RCT) in the world investigating the use of sirolimus-coated balloons for treating peripheral artery disease (PAD).

The SirPAD trial aims to compare the safety and efficacy of the sirolimus-coated MagicTouch PTA balloon against traditional uncoated balloons in patients with femoropopliteal and below-the-knee artery diseases. Patients enrolled will be monitored over 12 months, focusing on the primary outcome of major adverse limb events (MALE). The final results are anticipated to be released in the first or second quarter of 2026.

This multicentric, open-label, and investigator-initiated trial seeks to establish whether the MagicTouch PTA balloon is non-inferior to traditional balloon angioplasty and has the potential to outperform it. Leading the ambitious study are esteemed principal investigators, Prof. Dr. med. Nils Kucher and Prof. Dr. med. Stefano Barco, from the University Hospital Zurich. They emphasize the transformative potential of sirolimus-coated balloons in treating symptomatic PAD, highlighting that robust RCT data is essential for informing treatment guidelines.

Professors Kucher and Barco stated, “The successful randomization of such a substantial patient cohort in a PAD device trial is unprecedented. We extend our gratitude to all participating researchers and patients for their unwavering support.”

Concept Medical, based in Tampa, Florida, prides itself on its commitment to patient care through innovative drug-delivery technologies. Their patented platforms are designed to deliver pharmaceutical agents precisely to vascular luminal surfaces, significantly enhancing treatment efficacy. The MagicTouch family of sirolimus-coated balloons has gained recognition for its versatility and effectiveness in treating both coronary and peripheral artery diseases. Remarkably, these groundbreaking products have been utilized to treat over one million patients worldwide, setting a new standard for vascular therapy.

The SirPAD trial builds on the success of previous studies like SIRONA, which examined the superficial femoral artery (SFA) and demonstrated non-inferiority against paclitaxel-coated balloons. With the completion of the SirPAD enrollment, Concept Medical is positioned at the forefront of clinical research in vascular innovations, reinforcing its status as a global leader in patient-focused technologies.

As the global emphasis on sirolimus-coated balloons grows, the SirPAD trial represents a critical step in consolidating evidence supporting these treatment options. While the therapeutic pathways for PAD patients are limited, this major RCT aims to strengthen the clinical landscape and provide definitive data that could redefine treatment modalities. Concept Medical's founder and CEO, Dr. Manish Doshi, further expressed pride in achieving this historic milestone, signaling the company’s dedication to advancing vascular care through rigorous clinical research.

For more information about Concept Medical and its innovative technologies, please visit Concept Medical's website.

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