The first trial to test whether medicated, drug-eluting stents can benefit patients with peripheral arterial disease (PAD) is taking place at Montefiore Medical Center in Bronx, N.Y.
The trial will attempt to determine the safety and effectiveness of the Zilver PTX drug-eluting stent in treating blockages in the femoropoliteal artery, the major artery in the thigh.
The new stent is coated with paclitaxel, a drug derived from the Pacific yew tree that has been used successfully to reduce the risk of renarrowing of arteries.
"Combining a stent designed to hold blood vessels open to allow blood to flow freely through the vessel, with a medication used to prevent renarrowing, may reduce the development of scar tissue, the primary cause of the stent failure, in the months following balloon angioplasty in leg arteries. This helps eliminate the need for more invasive treatment, such as bypass surgery," said Evan Lipsitz, MD, chief of vascular surgery at Montefiore and principal investigator of the study.
The disease affects more than 10 million Americans, restricting circulation in blood vessels that lead from the heart to other areas of the body, such as the legs and feet. PAD often goes undiagnosed, resulting in pain when walking. It can lead to gangrene and amputation and may also signal an increased risk for coronary arterial disease and other related circulatory conditions, according to the Peripheral Arterial Disease Coalition.