A prospective , multicenter , single-blind trial comparing the Lutonix DCB ( Bard Lutonix ; New Hope , MN ) versus PTA for treatment of femoropopliteal PAD ( LEVANT 2 ) is the first US-based 2:1 randomized controlled trial of 476 patients with femoral-popliteal PAD designed to demonstrate superior efficacy and noninferior safety of a novel paclitaxel DCB compared with PTA .