Presented by Sean Lyden, M.D. at Vascular Interventional Advances (VIVA) 2017 conference in Las Vegas).
This prospective, multicenter, nonrandomized, single-arm trial is one of the largest prospective series to evaluate the percutaneous treatment of femoropopliteal blockages with lengths of 25 cm to 45 cm. The primary patency rate was 88.9% at 6 months with optimal device placement, and an overall primary patency rate of 76.9%. Delivery of devices and removal of the delivery system was successful in 100% of lesions. Improvement in Rutherford class of at least two grades was observed in 92% of patients; 94% of subjects improved ≥ one class over baseline at 6 months.