SIRONA Trial: Head-to-Head Comparison of Sirolimus-Coated vs. Paclitaxel-Coated Balloons for Femoropopliteal Artery Disease

JENA, Germany, May 25, 2021 /PRNewswire/ -- specializing in vascular interventional drug delivery devicesConcept Medical Inc. has releasedSIRONALatest Updates on Randomized Controlled Trials (RCTs). SIRONA'sWest`Romosozumab`and Paclitaxel Drug-Eluting Balloon Angioplasty in Femoropopliteal Artery LesionsTreatmentconduct in the field of treatmentDirect comparison study.

SIRONA is the world's first study to use a sirolimus drug-coated balloon (DCB) (MagicTouch PTA– Concept Medical) versus paclitaxel-coated balloon for the treatment of femoropopliteal artery lesions: a randomized controlled trial.

The SIRONA trial is an investigator-initiated, prospective, multicenter, core laboratory-adjudicated randomized trial designed to compare and evaluate the safety and efficacy of sirolimus-coated balloons versus paclitaxel-coated balloons (CE-marked devices) in treating stenotic or occlusive lesions of the superficial femoral artery (SFA) and/or popliteal artery (P1 segment) in patients with peripheral artery disease (PAD; Rutherford category 2–4). This study will enroll a total of 478 patients, randomized in a 1:1 ratio, across 30 sites in Germany and Austria (MagicTouch PTA: paclitaxel-coated balloon). Led by Principal Investigator Prof. Dr. Ulf Teichgräber at University Hospital Jena, Germany, the trial is currently progressing rapidly, with 20 patients already enrolled.

In Europe and North America, lower extremity peripheral artery disease (PAD) affects approximately 250,000 adults and is associated with significant morbidity and mortality, with atherosclerosis being the primary cause. Symptomatic PAD presents as claudication, which can progress to critical limb ischemia (CLI), with a mortality rate of 20% within the first five years, rising to 50% thereafter.

Percutaneous transluminal angioplasty (PTA) and plain old balloon angioplasty (POBA) have been widely employed as therapeutic interventions, utilizing uncoated balloons for arterial dilation; however, their success rates remain limited, as many patients present with recurrent restenosis or occluded lesions. Historically, drug-eluting stents incorporating antiproliferative agents were utilized to mitigate neointimal hyperplasia and stenosis to a certain extent. Recently, drug-coated balloons (DCBs) delivering similar pharmacological agents (paclitaxel and sirolimus analogs) have been effectively applied for the treatment of stenotic SFA lesions and are increasingly becoming the preferred therapeutic strategy. Currently, all commercially available DCBs indicated for peripheral arterial treatment are coated with paclitaxel. In light of the safety concerns surrounding paclitaxel, it is imperative to explore alternative pharmacological agents to replace it.

SIMRONAThe primary objective of the trial is to evaluate the safety and efficacy of a sirolimus-coated balloon for the treatment of SFA lesions. The primary efficacy endpoint is 12-month patency, defined as freedom from target lesion revascularization (TLR) or restenosis, while the primary safety endpoint is a composite of freedom from device- or procedure-related death and major target limb amputation within 12 months. The trial will include all patients with SFA lesions, whether de novo or restenotic, across Rutherford classification categories 2–4, presenting with either intermittent claudication or critical limb ischemia (CLI).

In the past, paclitaxel-coated balloons have been used to treat femoropopliteal artery lesions in PAD, but with limited success. The SIRONA trial is currently the first trial conducted globally, evaluating sirolimus-coated balloons（MagicTouch PTA) and paclitaxel-coated balloons in a head-to-head comparison to gather further evidence on patient safety. MagicTouch PTA has been granted Breakthrough Device Designation by the U.S. FDA for the treatment of BTK indications.

Ulf Teichgräber (Professor, Dr.) expressed optimism regarding the trial: "I believe that by providing new evidence on how to perform PTA under the 'Leave Nothing Behind' principle, SIRONA will be a groundbreaking trial."