SIRONA Randomized, Controlled Trial Comparing Sirolimus Versus Paclitaxel Balloons for the Treatment of Peripheral Arterial Disease Progresses Rapidly
May 26, 2021 — Concept Medical Inc., focused on vascular intervention drug delivery devices, released a status update from the SIRONA Randomized Control Trial (RCT). This trial compares, head-to-head, SIROlimus versus Paclitaxel Drug-Eluting BallooN Angioplasty in femoropopliteal arterial disease.
SIRONA is the world’s first RCT investigating the use of sirolimus drug-coated balloon (DCB) (MagicTouch PTA, Concept Medical) versus a paclitaxel DCB for the treatment of femoropopliteal artery disease.
SIRONA is an investigator-initiated and driven, prospective, multi-center, core lab-adjudicated randomized trial to compare and evaluate the safety and efficacy of a sirolimus-coated balloon versus a paclitaxel-coated balloon (CE-certified devices) in the treatment of stenosed or occluded lesions in the superficial femoral artery (SFA), and/or popliteal artery (P1) in peripheral arterial disease (PAD) patients with Rutherford classification 2 to 4. The study will enroll a total of 478 patients randomized 1:1 (MagicTouch PTA Paclitaxel-Coated Balloon) across 30 sites in Germany and Austria. Led by principal investigator Prof. Dr. Ulf Teichgräber, of Jena University Hospital, Germany, the study is moving rapidly with 20 patients already enrolled.
Lower extremity PAD affects estimated quarter million adults in Europe and North America, and is associated with significant morbidity and mortality, with atherosclerosis being the main cause. Symptomatic PAD presents as claudication and can progress into critical limb ischemia (CLI), with a 20% mortality in the first five years that increases to 50% after five years.
Percutaneous transluminal angioplasty (PTA) with plain old balloon angioplasty (POBA) has been widely used as the treatment and involves expansion of the arteries with an uncoated balloon, but with limited success, as many patients come back with restenotic or occluded lesions. Drug-eluting stents have been used in the past with anti-proliferative drugs that reduce the neointimal hyperplasia and stenosis to some extent. DCBs have been used to effectively treat a stenosed SFA with similar drugs (paclitaxel and -limus analogues) recently and are becoming the go-to option. Currently, the commercially available DCBs for peripheral arteries are coated with paclitaxel.
The primary objective of the SIRONA trial is to determine the safety and efficacy of a sirolimus-coated balloon application in SFA with the primary endpoint of patency at 12 months, defined as absence of target lesion revascularization (TLR) or restenosis, and primary safety endpoint defined 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 CLI.
In the past, paclitaxel-coated balloons have been used, with limited success, in the treatment of femoropopliteal arteries in PAD. The SIRONA trial is currently the first trial worldwide that is ongoing to collect additional evidence on patient safety with a head-to-head comparison of a sirolimus-coated balloon (MagicTouch PTA) and a paclitaxel-coated balloon.
MagicTouch PTA has been assigned a breakthrough device designation by the U.S. FDA for a below-the-knee (BTK) indication.
Prof. Dr. Ulf Teichgräber commented, “I believe that SIRONA will be a game-changer trial, giving new evidence on how to perform PTA following the principle of nothing left behind.”
About MagicTouch PTA:
MagicTouch PTA is the first drug-coated balloon that has been assigned a “Breakthrough Device Designation” by the U.S. Food and Drug Administration (FDA), for the treatment of below-the-knee lesions in PAD. MagicTouch PTA is a CE-approved and commercially marketed sirolimus-coated balloon, developed using proprietary Nanolute Technology. The drug delivery technology platform of MagicTouch PTA balloon is designed to deliver sub-micron particles of sirolimus to reach the deepest layers of the vessel walls.
About Concept Medical:
Concept Medical is headquartered in Tampa, Florida and has operational offices in The Netherlands, Singapore, and Brazil, and manufacturing units in India. Concept Medical specializes in developing drug-delivery systems, and has unique and patented technology platforms that can be deployed to deliver any drug/pharmaceutical agent across the luminal surfaces of blood vessels.
