Concept Medical has released a series of status updates on their head-to-head SIRONA (Sirolimus versus paclitaxel drug-eluting balloon angioplasty in femoropopliteal diseases) randomised controlled trial (RCT).
SIRONA is an investigator-initiated and -driven, prospective, multicentre, corelab-adjudicated trial involving peripheral arterial disease (PAD) patients with Rutherford classification 2–4. The study will enrol a total of 478 patients randomised 1:1 (MagicTouch PTA, Concept Medical: paclitaxel-coated balloon) across 30 sites in Germany and Austria. Led by Ulf Teichgräber (Jena University Hospital, Germany), a press release states that the study is moving “rapidly,” with 20 patients already enrolled.
According to a press release, SIRONA is the world’s first RCT investigating the use of a sirolimus drug-coated balloon (DCB) versus a paclitaxel DCB for the treatment of femoropopliteal artery disease.
The primary objective of the SIRONA trial is to determine the safety and efficacy of sirolimus-coated balloon application in the superficial femoral artery (SFA). The primary endpoint of patency at 12 months has been defined as absence of target lesion revascularisation [TLR] or restenosis and the primary safety endpoint determined as composite of freedom from device- or procedure-related death at 12 months as well as major target limb amputation.
The trial will include all patients with a disease in the SFA segment (either de novo or restenotic) falling under Rutherford class 2–4 and suffering from intermittent claudication to chronic limb-threatening ischaemia (CLTI).
Teichgräber communicates his optimism regarding the trial: “I believe that SIRONA will be a game changer trial by giving new evidence on how to perform PTA [percutaneous transluminal angioplasty] following the principle of nothing leaving behind.”