The DES BTK Vascular Stent System vs PTA in Subjects With Critical Limb Ischemia

A global, prospective, multicenter, 2:1 randomized trial evaluating the safety and effectiveness of the DES BTK Vascular Stent System compared to standard percutaneous transluminal angioplasty to treat infrapopliteal artery lesions in subjects with critical limb ischemia(CLI). Approximately 201 subjects will be randomized/enrolled to support a 2:1 randomization.