Bard Announces Completion of Enrollment in LEVANT 2 Trial for Lutonix Drug-Coated Balloon
July 25, 2012—C. R. Bard, Inc. (Murray Hill, NJ) announced that patient enrollment has been completed in its global, multicenter LEVANT 2 randomized clinical trial. The study seeks to compare the safety and efficacy of Bard’s Lutonix paclitaxel-coated percutaneous transluminal angioplasty dilatation catheter balloon (DCB) to a standard angioplasty balloon for the treatment of peripheral arterial disease. LEVANT 2 is a pivotal trial conducted under an investigational device exemption (IDE).
Bard announced the acquisition of Lutonix, Inc. (Maple Grove, MN) on December 20, 2011. The Lutonix DCB received CE Mark approval in 2011 and is commercially available in Europe. The device is not commercially available in the United States and is limited to IDE use.
The trial randomized 476 patients with diseased femoropopliteal leg arteries at 55 centers worldwide. The patients will be followed for 5 years and independent laboratories will verify trial outcomes. Kenneth Rosenfield, MD, and Dierk Scheinert, MD, are the Coprincipal Investigators of the trial. More information is available on the trial’s Web site, www.levant2.com.
“LEVANT 2 has been carried out to a degree of academic rigor that is unprecedented in this disease state,” commented Dr. Rosenfield in the Bard press release. “The controlled design of this trial is one that will offer us the first-in-kind results and insights on the role of drug-coated balloons for this population. I congratulate my fellow investigators and colleagues around the world for this major accomplishment, as well as Lutonix for conducting such a model clinical trial.”
Professor Scheinert added, “We have been discussing for several years the need for a definitive clinical trial to assess the true benefit of this potentially game-changing technology, and I'm proud to be part of the first team to achieve this scientifically significant milestone.”
Bard advised that it expects to release 2-year follow-up data from LEVANT 1 later this year. LEVANT 1 is a 101-patient, first-in-human, multicenter, randomized trial of the Lutonix DCB.
In addition, the company announced that it has obtained US Food and Drug Administration approval for the LEVANT 2 Continued Access Registry. The first patient was enrolled on June 19 in Belgium. The registry will enroll an additional 650 patients at 70 centers worldwide.