Concept Medical announced today that it has already enrolled 15 patients in a trial of its drug-coated balloon (DCB) for peripheral artery disease (PAD).
Tampa, Florida-based Concept Medical’s LIMES prospective multi-center randomized controlled trial to evaluate the safety and efficacy of below-the-knee (BTK) sirolimus drug-coated balloon against standard angioplasty for the treatment of infrapopliteal occlusions in patients with PAD.
Co-principal investigators Dr. Ulf Teichgräber and Thomas Zeller and Dierk Scheinert are leading the trial, which was initiated by the University Hospitals Jena and Leipzig in Germany. It will evaluate the MagicTouch — PTA 0.014″ and 0.018″ compared to POBA (plain old balloon angioplasty) in a 1:1, head-to-head comparison. The first patient was enrolled on March 31 by Dr. Nassan Malyar at the University Hospital Münster in Germany.
The trial will enroll 230 patients across 19 centers in Germany and Austria. The patient population will include patients presenting with documented chronic critical limb ischemia (CLI) in the target limb defined as Rutherford clinical category (RCC) 4, 5 or 6 aged ≥18 years.
No minimal leasion length will be required, with no lesion length limitation and no limitation in the number of used devices for enrollees. Follow-up will be done via in-house visits at 30 days, six months, 12 months, 24 months and 36 months, according to a news release.
Primary endpoints are the composite of limb salvage and primary patency through 6 months. The secondary safety endpoint is the composite of major adverse limb events (MALE) and perioperative death (POD) at 30 days.
MagicTouch PTA holds FDA breakthrough device designation for treating below-the-knee lesions in PAD. It has CE mark in Europe and uses proprietary nanolute technology, a drug delivery platform for delivering sub-micron particles of sirolimus to reach the deepest layers of the vessel walls.
The company said evaluating the sirolimus-coated balloon in this type of complex setting for treating PAD will “add weight and value” to the device as “the future of peripheral intervention.”
“BTK revascularization deals with the most challenging vascular territory in very sick patients,” Teichgräber said in the release. “LIMES will solve the question if sirolimus balloon angioplasty has the potential to become the future standard of care in BTK interventions.”