Physicians at Hutchinson Regional Medical Center enrolled their first patient in LEVANT 2, a global, multicenter, randomized clinical trial evaluating the safety and efficacy of the Moxy™ Drug Coated Balloon for the treatment of peripheral arterial disease (PAD). Michael Hagley, M.D., an interventional cardiologist and cardiac cath lab medical director at Hutchinson Regional’s Heart and Vascular Center, performed the case.
LEVANT 2, sponsored by medical device manufacturer Lutonix, Inc., is the first drug-coated balloon pivotal trial to be approved by the FDA. Hutchinson Regional is one of 55 centers around the world participating in the trial, which is expected to randomize 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 reblockage over time.
LEVANT 2 is the largest randomized peripheral drug-coated balloon clinical trial to date, and one of the largest peripheral vascular studies ever conducted. Randomized patients in LEVANT 2 will be followed for a total of 5 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 1 year from amputation, re-intervention, and death. The primary efficacy endpoint is primary patency at 1 year.
“We are excited to be part of this study as it’s the first step in a new frontier of medicine – the combining of mechanical and pharmacological treatment for treating patients with peripheral artery disease. We’re honored to be one of hospitals chosen to participate in this research,” said Dr. Hagley.
Drug-coated balloons are similar to standard angioplasty balloons except they are coated with an anti-restenotic drug aimed at preventing the artery from becoming blocked again. During the procedure, the Moxy balloon is inserted inside the narrowed area of the artery and then inflated in order to open the blockage and deliver the drug to the artery. After this short inflation, the balloon is removed from the body, leaving nothing but the drug behind in the artery.
LEVANT 2 is a follow-up trial to LEVANT 1, which was a 101-patient multicenter randomized 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.
“In trials of this magnitude and scientific rigor, it is imperative to have world-class research centers as your partners in the process. Hutchinson Regional Medical Center is such an institution, and we are deeply appreciative of the commitment and resources they have dedicated to successfully enrolling this trial,” said Dr. Dennis Wahr, CEO and co-founder of Lutonix.
Hutchinson Regional is a not-for-profit, 200-licensed bed, acute-care hospital serving the health needs of more than 65,000 residents of Hutchinson and Reno County, as well as the surrounding Central Kansas region. At the hospital’s Heart and Vascular Center, cardiologists pioneer new techniques, conduct revolutionary clinical trials and perform life-saving diagnostics and procedures using advanced technology often not found in larger metropolitan hospitals.
Highly regarded for a collaborative approach, the team of cardiothoracic and vascular surgeons, cardiologists and radiologists work together daily to blend their expertise in evaluations and treatments for the benefit of each of our patients.
About the Moxy Drug Coated Balloon
The Moxy balloon is very similar to a standard angioplasty balloon, but is coated with an antirestenotic drug designed to help keep arteries open and free from re-blockage. During the procedure, the Moxy balloon is inflated for 30-seconds during which it opens up the artery to restore blood flow, and delivers the drug into the artery wall. The Moxy balloon is then removed from the body leaving nothing behind but the drug coating, which works inside the artery over time to prevent restenosis. The Moxy balloon is an investigational device, which is not approved for, or available for sale in, the United States.
About Restenosis
Restenosis refers to the re-narrowing of an artery following angioplasty or stenting. Restenosis is caused by an overgrowth of tissue inside the artery, typically in response to arterial injury at the original treatment site. Restenosis often occurs within the first 6 months following an intervention, and most often results in re-treatment.