Self-Expanding Nitinol Stent Versus Balloon Angioplasty Alone for the Below The Knee Arteries(SENS-BTK)

Inclusion Criteria: * Symptomatic critical limb ischemia (Rutherford 4 - 6) * Patients with signed informed consent * Target lesion length \< 8 cm by angiographic estimation * Stenosis of \>50% or occlusive atherosclerotic lesion of the ipsilateral infrapopliteal artery * Reference vessel diameter should be 2.0-4.5 mm Exclusion Criteria: * Patient has a known allergy to heparin, aspirin, or other anticoagulant/antiplatelet therapies or a bleeding diatheses or is unable, or unwilling, to tolerate such therapies * Patient takes warfarin * Patient has a history of previous life-threatening contrast media reaction * Patient is currently enrolled in another investigational device or drug trial * Patient is currently breast-feeding, is pregnant, or intends to become pregnant * Patient is mentally ill or retarded * Acute critical limb ischemia * Major bleeding history within prior 2 months * Severe hepatic dysfunction (\> 3 times normal reference values) * Significant leucopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis * Life expectancy \<1 year due to comorbidity * Reference segment diameter is not suitable for available stent design * Previously implanted stent(s) or PTA at the same lesion site * Inflow-limiting arterial lesions left untreated