Lutonix has enrolled its first patient in the LEVANT 2 clinical trial, a global, multi-center, randomized trial evaluating the safety and efficacy of the Moxy(TM) Drug Coated Balloon compared to a standard angioplasty balloon for the treatment of peripheral arterial disease (PAD). The first case was performed at St. John's Hospital in Springfield, Ill., by Dr. Jeff Goldstein.
LEVANT 2 is the first drug-coated balloon IDE trial to be approved by the FDA, and is being conducted to support a PMA application for U.S. approval of the company's Moxy balloon. The trial is expected to randomize approximately 476 patients at up to 55 hospitals worldwide. LEVANT 2 is the largest randomized peripheral drug-coated balloon 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 five years and independent core laboratories will 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. Dr. Kenneth Rosenfield (Massachusetts General Hospital, Boston, Mass.) and Prof. Dierk Scheinert (Heart Center Leipzig/Park Hospital, Leipzig, Germany) are the co-principal investigators of the trial.
Drug-coated balloons have received growing attention in recent years as physicians increasingly look for effective ways to treat diseased leg arteries without having to leave a permanent stent implant behind. Like the drug-eluting stents commonly used in the heart, the Moxy balloon delivers a powerful restenosis-fighting drug to the artery. However, unlike a stent, the Moxy balloon is removed from the body after use, leaving nothing but the drug behind in the artery.
Physician enthusiasm for the drug-coated balloon concept has been bolstered by encouraging results from early trials like LEVANT 1, a precedent study to LEVANT 2. LEVANT 1 was a 101-patient randomized trial in which the Moxy balloon was compared to standard angioplasty for the treatment of diseased femoropopliteal arteries. The trial showed the Moxy balloon had the ability to safely and substantially inhibit restenosis.