Drug-coated balloon trial reinventing treatment possibilities

CLEVELAND, Jan. 24, 2012 /PRNewswire/ -- Physicians at University Hospitals (UH) Case 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). 

Co-investigators Sahil Parikh, MD,  Michael Cunningham MD, and Vikram Kashyap, MD, 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 medical device manufacturer Lutonix, Inc., is the first drug-coated balloon pivotal trial to be approved by the FDA. UH Case Medical Center 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 re-blockage over time.

"The drug coated balloon is a novel approach for treating PAD -- 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 Dr. Parikh, a cardiovascular medicine specialist with UH Case Medical Center, and Assistant Professor at Case Western Reserve University School of Medicine. "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."

According to Dr. Parikh, the latest drug coating technology for balloons was adapted from concepts applied to medicated stents during heart catheterizations.

"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 Dr. Parikh.

LEVANT 2 is the largest randomized peripheral drug-coated balloon clinical trial to date, and one of the largest peripheral vascular studies ever conducted. Currently, University Hospitals currently ranks as the highest enrolling site in the region as well as among the top 10 in the world for enrollment. 

Randomized patients in LEVANT 2 will be followed for a total of five 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 one year from amputation, re-intervention, and death.  The primary efficacy endpoint is primary patency at one year. 

"We believe this trial may lead to a substantially better treatment option for patients with PAD," said Dr. Kashyap, UH Case Medical Center's Division Chief of Vascular Surgery and Professor at Case Western Reserve University School of Medicine "We are very proud of our ability to contribute to this important research and include ourselves in such a prestigious group of investigators around the world."

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 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-on 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.  UH Case 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.

About the Moxy Drug Coated Balloon
The Moxy balloon is very similar to a standard angioplasty balloon, but is coated with an anti-restenotic 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 University Hospitals
University Hospitals serves the needs of patients through an integrated network of hospitals, outpatient centers and primary care physicians.  At the core of our health system is University Hospitals Case Medical Center.  The primary affiliate of Case Western Reserve University School of Medicine, University Hospitals Case Medical Center is home to some of the most prestigious clinical and research centers of excellence in the nation and the world, including cancer, pediatrics, women's health, orthopedics and spine, radiology and radiation oncology, neurosurgery and neuroscience, cardiology and cardiovascular surgery, organ transplantation and human genetics. Its main campus includes the internationally celebrated UH Rainbow Babies & Children's Hospital, ranked second in the nation for the care of critically ill newborns; UH MacDonald Women's Hospital, Ohio's only hospital for women; and UH Ireland Cancer Center, part of the NCI-designated Case Comprehensive Cancer Center. For more information, go to www.uhhospitals.org

SOURCE University Hospitals Case Medical Center

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