JENA, Germany — Concept Medical Inc., focused on vascular intervention drug delivery devices, releases status updates of SIRONA Randomized Control Trial (RCT) which compares head-to-head, SIROlimus versus Paclitaxel Drug-Eluting BallooN Angioplasty in femoropopliteal arterial diseases (SIRONA).
SIRONA is an Investigator-Initiated and driven, prospective, multi-center, corelab adjudicated randomized trial to compare and evaluate the safety and efficacy of Sirolimus Coated balloon versus 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 the 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), pointing at 20% mortality in the first five years and the rate increasing to 50% post five years.
Percutaneous Transluminal Angioplasty (PTA) with plain old balloon angioplasty (POBA) has been widely used as the treatment which 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 which reduces the neointimal hyperplasia and stenosis to some extent. DCBs have been used to effectively treat the 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. Given all the safety issues with Paclitaxel, there is need to explore other drugs to replace Paclitaxel.
The primary objective of the SIRONA trial is to determine the safety and efficacy of Sirolimus Coated Balloon application in SFA with the primary endpoint of patency at 12 months defined as absence of TLR 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. 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 Balloon has been used, with limited success, in the treatment of femoropopliteal arteries in PAD. 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 Sirolimus Coated Balloon (MagicTouch PTA) and Paclitaxel Coated Balloon. MagicTouch PTA has been assigned a breakthrough device designation by the US FDA for BTK indication.
Prof. Dr. Ulf Teichgräber shows his optimism regarding the trial with a positive note, “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.”