The first U.S. trial to test whether drug-eluting stents, which have had rapid success in treating coronary artery disease, offer similar benefits in treating diseased arteries outside the heart is under way with the first patient treated earlier this week at Stanford University Medical Center.
The trial is testing the safety and effectiveness of the Zilver PTX paclitaxel-eluting stent developed by Cook, Bloomington, Ind., to clear blockages in the major artery in the thigh. The trial, which compares the drug-eluting stent to standard interventions for peripheral artery disease, initially will enroll 60 patients at 10 U.S. medical facilities with an expanded trial likely, pending review by the Food and Drug Administration, Cook officials said.
Peripheral artery disease affects more than 10 million Americans and can be a predictor of cardiovascular disease or stroke. Risk factors include smoking, diabetes and high blood pressure.