The global, multicenter, randomized clinical trial, which will enroll 476 patients with diseased femoropopliteal leg arteries, is designed to assess the the safety and efficacy of the Moxy Drug Coated Balloon for the treatment of peripheral arterial disease (PAD).
The Moxy balloon is coated with an anti-restenotic drug which is designed to help keep arteries open and free from re-blockage.
The trial will investigate whether the Moxy balloon is more effective than standard angioplasty at keeping leg arteries open and free from re-blockage over time.
UH Case Medical Center said the randomized patients in LEVANT 2 will be followed for a total of five years and independent core laboratories will be utilized to verify trial outcomes.
The primary safety endpoint is a composite of freedom from all-cause peri-operative death and freedom at one year from amputation, re-intervention, and death.
The primary efficacy endpoint is primary patency at one year.
UH Case Medical Center cardiovascular medicine specialist Parikh said the advantage of a drug coated balloon is that it does not require the placement of a stent to be effective, and they believe, will prove to be an excellent alternative therapy to surgical bypass, especially points of flexion in the leg or at the knee, where placement of a metal stent would possibly lead to ultimate fracture of the stent.
