Enrollment Begins for LEVANT II Trial of the Lutonix Moxy Drug-Coated Balloon

July 25, 2011—Lutonix, Inc. (Maple Grove, MN) announced commencement of LEVANT II, a global, multicenter, randomized clinical trial evaluating the safety and efficacy of the company's Moxy drug-coated balloon compared to a standard angioplasty balloon for the treatment of peripheral arterial disease (PAD).

According to the company, LEVANT II is an investigational device exemption trial that is being conducted to support a premarket approval application to the US Food and Drug Administration for the Moxy balloon. The trial is expected to randomize approximately 476 patients at up to 55 hospitals worldwide. Randomized patients will be followed for a total of 5 years, and independent core laboratories will verify trial outcomes.

The primary safety endpoint is a composite of freedom from all-cause perioperative death and freedom at 1 year from amputation, reintervention, and death. The primary efficacy endpoint is primary patency at 1 year. Kenneth Rosenfield, MD, and Dierk Scheinert, MD, are the Coprincipal Investigators of the trial. Jeff Goldstein, MD, a site Principal Investigator at St. John's Hospital in Springfield, Illinois, enrolled the first patient.

“We are very pleased to be the first center to contribute to such an important trial,” commented Dr. Goldstein. “We believe drug-coated balloons may play an important role in the future of peripheral interventions, and we are proud to be involved in such a well-designed, carefully controlled trial to explore this promising new therapy.” 


Co-Investigator Krishna Rocha-Singh, MD, added, “With 8 to 12 million patients known to suffer from PAD and a paucity of durable, highly effective therapies, patients and physicians are in need of a game-changing treatment modality. The LEVANT II trial will help us determine whether a drug-coated balloon can fill this gap.”
 

As reported in Endovascular Today, positive results from the LEVANT I study of the use of drug-eluting balloons to treat PAD were presented in September 2010 at the Transcatheter Cardiovascular Therapeutics scientific symposium in Washington, DC. LEVANT I 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 that the Moxy balloon had the ability to safely and substantially inhibit restenosis, the company stated.

“There is tremendous enthusiasm within the medical community about the potential for drug-coated balloons to improve outcomes for our patients,” commented Dr. Rosenfield. “However, because the field is young, we need data from large, randomized, controlled clinical trials that are independently validated. Because of its scientific rigor, LEVANT II will help address this need. On behalf of Dr. Scheinert and myself, we congratulate St. John's on their enrollment of the first patient in this landmark trial.”