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Saint Joseph Mercy Health System

Groundbreaking treatment for leg blockages
Start Date
Patient at St. Joseph Mercy Ann Arbor is one of first in Michigan to undergo drug-coated balloon angioplasty in international trial to treat leg blockages

Peripheral arterial disease (PAD) is a debilitating condition of the limbs that effects 8-12 million Americans – symptoms result from blocked leg arteries and may include aching, cramping, heaviness, and numbness, which can result in poor quality of life, reduced ability to function, limb loss and even death. Researchers are making great strides in treating PAD thanks to a landmark international, study, called 'LEVANT 2.'

On Friday at St. Joseph Mercy Ann Arbor, one of the first patients in the state of Michigan, underwent a drug-coated balloon angioplasty procedure as part of the LEVANT 2 study, the largest randomized drug-coated balloon trial to date and one of the largest peripheral vascular studies ever conducted. St. Joseph Mercy is one of only 40 sites in the country and 55 worldwide offered the opportunity to participate. Doctors indicate the procedure was successful and the patient has already fully recovered and notes substantial improvement in their ability to walk

The drug-coated balloon delivers a powerful drug to the artery that fights re-narrowing of the vessel. However, unlike a stent, the balloon is removed from the body after use, leaving nothing behind but the drug in the artery. Drug-coated balloons have received growing attention in recent years as physicians increasingly look for alternative ways to treat diseased leg arteries.

Peripheral arterial disease is a condition in which plaque builds up in the arteries that carry blood to the brain, limbs and organs other than the heart. Currently PAD is treated with medicine and when needed, minimally invasive angioplasty or open surgical procedures. Although angioplasty of the legs is less likely to result in serious complications than surgery, it is still fraught with higher rates of re-narrowing and stents, which can reduce such re-narrowing in places like the heart, have not enjoyed similar success in the legs. The LEVANT 2 trial, sponsored by Minnesota-based Lutonix, is seeking to prove that narrowed arteries will more likely stay open after the drug-coated balloon than the more traditional uncoated balloon.

“This study comes on the heels of encouraging research from Europe and may lead to a paradigm shift in how we treat patients with leg blockages,” commented Herbert D. Aronow, MD, MPH, cardiovascular medicine physician and LEVANT 2 trial principal investigator at St. Joseph Mercy Ann Arbor. “We believe this trial may offer a substantially better treatment option for patients with PAD.”

Randomized patients in this study will be followed for five years, with independent laboratories verifying the trial outcomes. The primary success indicators include: freedom from amputation, re-intervention and death.

The trial began in July 25 in Springfield, Ill.

“We are honored to participate in this important study and to be included among such a prestigious group of international investigators,” concludes Aronow.

For more information about LEVANT 2 trial, please contact Research Coordinator, Kristy Wippler or Site Principal Investigator Dr. Aronow at 734-712-8000.