World's Largest Study on Sirolimus-Coated Balloons Completes Patient Enrollment in the SirPAD Trial

SirPAD Trial: A Landmark in Peripheral Artery Disease Research

Concept Medical Inc. (CMI) has reached a significant milestone in clinical research with the successful completion of patient enrollment in the SirPAD Trial, marking it as the world’s largest randomized controlled trial (RCT) focused on the treatment of Peripheral Artery Disease (PAD). Over 1,250 patients have been enrolled to assess the effectiveness of the MagicTouch PTA Sirolimus Coated Balloon compared to traditional uncoated balloons. This ambitious study is expected to yield critical data that could shape treatment guidelines and options for PAD patients.

The SirPAD trial, officially titled “Major Adverse Limb Events in Patients with Femoro-Popliteal and Below-the-Knee Peripheral Arterial Disease Treated with Either Sirolimus-Coated or Uncoated Balloon,” aims to evaluate whether the innovative technology of sirolimus-coated balloons can provide better outcomes than the conventional treatment, which is plain old balloon angioplasty (POBA). This trial is particularly significant as it not only looks at non-inferiority but also explores the potential for superiority of the new device.

The Need for Robust Clinical Evidence
Principal Investigators Prof. Dr. Nils Kucher and Prof. Dr. Stefano Barco from the University Hospital Zurich have emphasized the importance of this study. They stated that sirolimus-coated balloons have previously demonstrated promise based on studies with surrogate endpoints. However, robust data from well-conducted RCTs with actual clinical outcomes are crucial for future treatment strategies. Together, these investigators have managed to randomize such a high number of patients in a PAD device study, which is unprecedented.

What the SirPAD Trial Aims to Achieve
Patients enrolled in the SirPAD trial will be monitored for a 12-month period to evaluate the primary outcome: major adverse limb events (MALE). The trial’s final results are anticipated by the first or second quarter of 2026. Given that patients suffering from PAD often have limited therapeutic options, the findings could provide substantive evidence to support sirolimus-coated balloon technology as a viable treatment alternative.

Dr. Manish Doshi, founder and Managing Director of Concept Medical, expressed pride in the completion of enrollment for this historic trial. He stated that following the successful SIRONA trial, which established a benchmark by comparing their device against paclitaxel drug-coated balloons, the SirPAD trial further solidifies CMI's role as a leader in innovation within this field.

The Role of Concept Medical in Advancing Vascular Therapies
Concept Medical is headquartered in Tampa, Florida, and is dedicated to improving patient outcomes through groundbreaking research and the development of advanced drug-delivery technologies. The company’s flagship product, the MagicTouch Sirolimus Coated Balloon, represents the first and most utilized technology in this category, recognized for its effectiveness in treating coronary and peripheral artery diseases. The product has been utilized in over a million treatments worldwide, and through ongoing research efforts like the SirPAD trial, Concept Medical aims to continue setting new benchmarks in vascular therapy.

As the healthcare landscape evolves and patients with PAD look for new options, the outcomes of the SirPAD trial could become instrumental in offering clearer insights and potentially revolutionizing standard treatment protocols. The commitment by Concept Medical and its research partners to develop solid clinical evidence reaffirm their pioneering status in the medical technology sector focused on patient-centric innovations.

For more detailed information about their innovative technologies and ongoing trials, please visit Concept Medical's Official Website.