ABSTRACT

Research Question/Objective Percutaneous transluminal angioplasty (PTA) of the infrapopliteal vessels is routinely performed to restore distal perfusion in patients with critical limb ischemia (CLI). The effectiveness of plain old balloon angioplasty (POBA) of the infrapopliteal arterial system has been limited due to high rates of restenosis and atherosclerotic disease progression. The central goal of this trial was to assess whether the use of drug-eluting balloons (DEBs) for infrapopliteal revascularization in CLI would result in improved safety and efficacy in comparison to traditional PTA.