Concept Medical’s MagicTouch Sirolimus-Coated PTA Balloon Evaluated in LIMES Trial for CLTI BTK Interventions
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Concept Medical Inc. announced the initiation of LIMES trial, which has enrolled 15 patients to evaluate the company’s CE Mark-approved MagicTouch sirolimus-coated percutaneous transluminal angioplasty (PTA) balloon catheter for the treatment of peripheral
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artery disease (PAD).
The randomized controlled trial (RCT) will measure the efficacy of the MagicTouch balloons in a complex setting of chronic limb-threatening ischemia (CLTI) of the PAD segment located below the P3 segment of the popliteal artery
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to the tibiotalar joint against the current standard of care.
LIMES is designed to enroll 230 patients at 19 centers across Germany and Austria.
The trial was initiated by the University Hospital Jena and the University Hospital Leipzig in Germany. It is led by Principal Investigator Professor Ulf Teichgräber, MD, with Coprincipal Investigator Professor Thomas Zeller, MD, and Professor Dierk Scheinert, MD. The first patient enrolled on by Nassan Malyar, MD, at the University Hospital Münster in Germany, on March 31, 2022.
Prof. Teichgräber commented on why the RCT is valuable in terms of drug-coated balloon intervention in infrapopliteal occlusions. He stated, “BTK revascularization 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.”
According to the company, LIMES is a prospective, multicenter, RCT to evaluate the safety and efficacy of the Magic Touch PTA 0.014-inch and 0.018-inch sirolimus-coated balloon versus standard plain old balloon angioplasty (POBA) for the treatment of infrapopliteal occlusions in patients with PAD. Patients will be randomized 1:1 to MagicTouch and POBA.
The patient population will include patients age ≥ 18 years presenting with documented chronic critical limb ischemia in the target limb, defined as Rutherford clinical category 4, 5, or 6. The study will evaluate patients with a reference vessel diameter ≥ 2.00 mm and ≤ 4.0 mm 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, and at 6, 12, 24, and 36 months.
The study’s primary endpoints are the composite of limb salvage and primary patency through 6 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 6, 12, and 24 months by duplex ultrasound and quantitative vascular angiography in case of any target lesion revascularization.
Concept Medical noted that MagicTouch features the company’s nanolute technology platform that delivers submicron particles of sirolimus to reach the deepest layers of the vessel walls.
In October 2019, Concept Medical announced Magic Touch PTA received CE Mark approval in Europe. In the United States, the company announced that it received FDA Breakthrough Device designation for the device for the treatment of PAD below the knee (BTK).
