A Randomized Trial comparing the Drug-Eluting Stent (DES) Below-the-Knee (BTK) Vascular Stent System (DES BTK Vascular Stent System) vs Percutaneous Transluminal Angioplasty (PTA) Treating Infrapopliteal Lesions in Subjects With Critical Limb Ischemia.
Brief description of study
The purpose of this two phased, prospective clinical trial is to demonstrate superior patency rate and acceptable safety in below the knee arteries with lesions treated with Drug-Eluting Stent (DES) Below the Knee (BTK) Vascular Stent System versus percutaneous transluminal angioplasty (PTA). This is a surgical procedure using a balloon catheter (thin tube with a tiny inflatable balloon) for the treatment of a blocked or narrowed blood vessels in the lower leg. The first part of the study will be randomized meaning the participant may be put into the stent or the PTA group by chance. The chance of being in the stent group is 2 to every 1 chance in the PTA group. The purpose of Phase B of study is to evaluate how well the device works. This study is looking to enroll patients with symptomatic lower limb ischemia who meet the study criteria.
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