Concept Medical has announced the successful completion of enrolment for the SIRONA randomised controlled trial (RCT) investigating the use of its Magic Touch PTA sirolimus drug-coated balloon (DCB) versus paclitaxel DCB angioplasty for the treatment of peripheral artery disease in the femoropopliteal vessel segment.
The prospective, multicentre, head-to-head, corelab adjudicated RCT enrolled a total of 480 patients across 28 sites in Germany and Austria. The target patient was enrolled on September 23, at Hanusch Hospital Vienna (Vienna, Austria) by principal investigator (PI) Martin Werner and team.
Coordinating principal investigator, Ulf Teichgräber, said: “I am thrilled to work with 28 highly dedicated and motivated study sites that have managed to complete enrolment much earlier than expected. 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.”
SIRONA will be a game changer trial, considering its bold design and the direct comparison against paclitaxel, say Concept Medical. The trial enrolled all patients with a 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).
The 12 month results will feature patency (defined as the absence of target lesion revascularisation (TLR) or restenosis), and the primary safety endpoint is assessed as the composite of freedom from device or procedure-related death at 12 months as well as major target limb amputation.
The University Heart Center (Bad Krozingen, Germany) topped the enrolment under the lead of Thomas Zeller.
“It is exciting that enrolments into the first head-to-head comparative study between a sirolimus coated DCB and a variety of marketed paclitaxel coated DCB for femoropopliteal indication could be finished in such a short time”, said Zeller. “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,” he added.
Magic Touch PTA has already been granted a breakthrough device designation by the US FDA for below-the-knee indication.