Physicians at University Hospitals (UH) Case Medical Center, USA, enrolled their first patient in LEVANT 2, a global, multicentre, randomised clinical trial evaluating the safety and efficacy of the Moxy drug-coated balloon for the treatment of peripheral artery disease.
Co-investigators Sahil Parikh, Michael Cunningham and Vikram Kashyap, with UH Harrington-McLaughlin Heart & Vascular Institute at UH Case Medical Center, were the first physicians to successfully implant the device in a patient.
LEVANT 2, sponsored by Lutonix, is the first drug-coated balloon pivotal trial to be approved by the FDA. UH Case Medical Center is one of 55 centres around the world participating in the trial, which is expected to randomise 476 patients with diseased femoropopliteal leg arteries.
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.
“The drug coated balloon is a novel approach for treating peripheral artery disease. Traditional therapies required bypass surgery, but as minimally invasive techniques have evolved, we have been able to offer procedures such as angioplasty and stent placement in the legs,” said Parikh, a cardiovascular medicine specialist with UH Case Medical Center, and assistant professor at Case Western Reserve University School of Medicine, USA. “The problem has been that these treatments have been hampered by renarrowing due to the in-growth of scar tissue into the arteries known as restenosis.”
“The advantage of a drug coated balloon is that it does not require the placement of a stent to be effective, and we 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,” said Parikh.
LEVANT 2 is the largest randomised peripheral drug-coated balloon clinical trial to date, and one of the largest peripheral vascular studies ever conducted. Currently, University Hospitals ranks as the highest enrolling site in the region as well as among the top 10 in the world for enrolment.
Randomised patients in LEVANT 2 will be followed for a total of five years and independent core laboratories will be utilised 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.
LEVANT 2 is a follow-on trial to LEVANT 1, which was a 101-patient multicentre randomised trial. Patients either received the Moxy balloon or standard angioplasty for the treatment of diseased femoropopliteal arteries. Based on the success and positive results of the LEVANT 1 trial, LEVANT 2 was designed to investigate the device in a larger patient population.