Concept Medical Completes Patient Recruitment for World's Largest Sirolimus Coated Balloon Trial

Concept Medical's SirPAD Trial Reaches Major Milestone

In a significant advancement for vascular medicine, Concept Medical Inc., a leader in innovative drug-delivery technologies, proudly announced the successful completion of patient recruitment for its groundbreaking SirPAD trial. In total, more than 1,250 patients have enrolled in this clinical study that is poised to explore the efficacy of the MagicTouch PTA— a pioneering sirolimus-coated balloon—in treating peripheral artery disease (PAD).

What is the SirPAD Trial?

The SirPAD trial (major adverse limb events in patients with femoropopliteal and infrapopliteal peripheral artery disease treated with sirolimus-coated or uncoated balloon) is distinguished as the world's largest study focused on evaluating the treatment impact of the MagicTouch PTA against conventional uncoated balloons. It is a randomized, controlled, multicenter clinical trial that aims to determine the non-inferiority of the sirolimus-coated balloon compared to standard balloon angioplasty (POBA).

The primary endpoint involves monitoring major adverse limb events (MALE) over a 12-month follow-up period for all enrolled participants, with the final results expected in the first quarter of 2026. The anticipation surrounding the study is driven by the need for more robust clinical data to guide treatment options effectively in this area.

Expertise Behind the Study

The principal investigators, Prof. Dr. Nils Kucher and Prof. Stefano Barco, leading figures in treating PAD at the University Hospital of Zurich, emphasized the critical relevance of this milestone. They noted, “Sirolimus-coated balloons represent a promising technology in the treatment of symptomatic PAD, supported primarily by data from studies utilizing surrogate endpoints.”

With ongoing trials like SirPAD, the medical community hopes to deepen the understanding of sirolimus technology, which has shown potential in previous studies and offers new avenues for patients whose treatment options have been historically limited.

Concept Medical's Commitment to Innovation

Dr. Manish Doshi, founder and CEO of Concept Medical, expressed pride in achieving another historical moment with the SirPAD trial following their previous successful SIRONA study. “After demonstrating non-inferiority in femoral superficial artery interventions, we are excited to extend our commitment to generating quality clinical data supporting innovative technologies in vascular healthcare,” said Dr. Doshi.

Concept Medical, headquartered in Tampa, Florida, is dedicated to enhancing patient care through advanced research and development of drug delivery technologies. Their innovative magic touch balloon technology has already led to the treatment of over one million patients globally, establishing a new standard in vascular therapy.

Next Steps

With the recruitment phase now concluded, the focus shifts to monitoring and data collection from the enrolled participants. As researchers evaluate the effectiveness and safety of the MagicTouch PTA, the SirPAD trial stands as a landmark study with the potential to influence future treatment protocols for patients suffering from PAD.

For ongoing updates and more information, visit www.conceptmedical.com.

Conclusion

The completion of patient enrollment for the SirPAD trial marks an exciting chapter in the exploration of vascular treatments and signifies a hopeful development for individuals affected by peripheral artery disease. As results unfold, the medical community watches closely, eager to glean insights that could reshape therapeutic approaches in this essential field.