Concept Medical has announced the completion of enrollment for the SIRONA trial, a randomized controlled trial (RCT) comparing the Magic Touch PTA sirolimus drug-coated balloon (DCB) with paclitaxel DCB angioplasty for treating peripheral artery disease (PAD) in the femoropopliteal segment. The trial enrolled 480 patients across 28 sites in Germany and Austria.
The SIRONA trial is a prospective, multi-center, head-to-head, corelab adjudicated RCT. The last patient was enrolled on September 23 at Hanusch Hospital Vienna. The study includes patients with disease in the superficial femoral artery (SFA) segment, whether de-novo or restenotic, falling into Rutherford classes 2–4, and experiencing intermittent claudication to critical limb ischaemia (CLI).
Trial Design and Endpoints
The primary endpoint at 12 months is patency, defined as the absence of target lesion revascularization (TLR) or restenosis. The primary safety endpoint is a composite of freedom from device or procedure-related death at 12 months, as well as major target limb amputation.
Ulf Teichgräber, coordinating principal investigator, stated, "SIRONA represents a breakthrough head-to-head RCT with the potential to usher in a new era of sirolimus DCB in peripheral arterial disease (PAD) to replace an old technology."
Significance of Sirolimus DCB
The trial is designed to compare sirolimus DCB against paclitaxel, addressing concerns and controversies surrounding the safety of paclitaxel. Sirolimus DCB treatment is already considered a safe and effective option in both coronary and peripheral artery disease. The Magic Touch PTA sirolimus-coated balloon has demonstrated promising safety and efficacy in lower extremity diseases across multiple studies.
Thomas Zeller, from the University Heart Center (Bad Krozingen, Germany), which topped the enrollment, noted, "The study has sufficient size and the power to demonstrate if there is at least equivalent performance between the Magic Touch DCB and a range of paclitaxel coated DCB and if so, if there are potential lesions which may even benefit from the use of a sirolimus coated DCB."
About Magic Touch PTA
Magic Touch PTA is a CE-approved and commercially available sirolimus DCB, developed using Nanolute Technology. This drug delivery technology platform is designed to deliver sub-micron particles of sirolimus to the deepest layers of the vessel walls. The device has already received breakthrough device designation from the US FDA for below-the-knee indication.
