Concept Medical Details Plans for SIRONA Trial of Sirolimus- Versus Paclitaxel-Coated Balloons

May 24, 2021—Concept Medical Inc. provided an update on the SIRONA trial, which compares its MagicTouch PTA sirolimus drug-coated balloon (DCB) versus a paclitaxel DCB for percutaneous transluminal angioplasty in femoropopliteal arterial disease.

According to the company, SIRONA is an investigator-initiated, prospective, multicenter, core lab–adjudicated randomized trial to compare and evaluate the safety and efficacy of a sirolimus-coated balloon versus a paclitaxel-coated balloon—both CE Mark–approved devices—in the treatment of stenosed or occluded lesions in the superficial femoral artery and/or popliteal artery in patients with peripheral arterial disease with Rutherford classifications 2 to 4.

SIRONA has enrolled 20 of a target total of 478 patients, who are being randomized 1:1 at 30 sites in Germany and Austria.

The company states that the primary objective of the SIRONA trial is to determine the safety and efficacy of sirolimus-coated balloon application in SFA, with a primary endpoint of patency at 12 months defined as absence of target lesion revascularization or restenosis and primary safety endpoint determined as composite of freedom from device- or procedure-related death at 12 months, as well as major target limb amputation.

"I believe that SIRONA will be a game-changer trial by giving new evidence on how to perform PTA following the principle of nothing leaving behind," commented SIRONA's principal investigator, Professor Ulf Teichgräber, MD, of Jena University Hospital in Jena, Germany, in the company's announcement.

In the United States, MagicTouch PTA has received Breakthrough Device designation from the FDA for a below-the-knee indication, advised Concept Medical.