Concept Medical has announced the initiation of the LIMES trial, which has enrolled 15 patients to evaluate the safety and efficacy of the company’s Magic Touch sirolimus-coated percutaneous transluminal angioplasty (PTA) balloon for the treatment of peripheral arterial disease (PAD).
A Concept Medical press release elaborates that LIMES is a prospective, multicentre, randomised controlled trial (RCT) that is designed and aimed to evaluate the Magic Touch balloon 0.014” and 0.018” versus standard angioplasty in a head-to-head comparison (1:1).
Initiated by the University Hospitals Jena and Leipzig in Germany and led by principal investigator (PI) Ulf Teichgräber (Jena University Hospital, Jena, Germany) alongside co-PI Thomas Zeller (University Heart Center Freiburg-Bad Krozingen, Bad Krozingen, Germany) and Dierk Scheinert (University Hospital Leipzig, Leipzig, Germany), the trial kicked off with the index patient enrolled on 31 March 2022 by Nassan Malyar at the University Hospital Münster in Münster, Germany.
LIMES RCT is set to enrol 230 patients in 19 centres across Germany and Austria. The patient population will include patients presenting with documented chronic limb-threatening ischaemia (CLTI) in the target limb defined as Rutherford clinical category 4, 5 or 6 aged ≥18 years. The study evaluates patients with a reference vessel diameter (RVD) ≥2 and ≤4mm and total occlusions (100% stenosis) of the target lesion. There is no minimal lesion length required, no lesion length limitation and no limitation in number of used devices. Follow-up will be per in-house visits at 30 days, six, 12, 24 and 36 months.
The RCT will measure the efficacy of sirolimus-coated balloons in a complex setting (CLTI) of the PAD segment (located below the P3 segment of the popliteal artery to the tibiotalar joint) against the current standard of care. The study’s primary endpoints are the composite of limb salvage and primary patency through six months. The key secondary safety endpoint is the composite of major adverse limb events and perioperative death at 30 days. A blinded core lab will assess patency at six, 12 and 24 months by duplex ultrasound and quantitative vascular angiography in case of any target lesion revascularisation.
In the press release, Teichgräber commented on why the RCT is valuable in terms of DCB intervention in infrapopliteal occlusions: “BTK [below-the-knee] revascularisation deals with the most challenging vascular territory in very sick patients. LIMES will solve the question if sirolimus balloon angioplasty has the potential to become the future standard of care in BTK interventions.”