FeMoropopliteal AngioSculpt™ SCoring BallOon CaTheter Study

Inclusion Criteria: * Stenotic (\>50%) or occlusive atherosclerotic disease of the femoropopliteal arteries (primarily superficial femoral arteries - SFA) * Length of lesion \>5 cm or 2 times the AngioSculpt balloon length (whichever is longer) * Reference vessel diameter should be 4.0-6.0 mm * Life altering claudication or critical limb ischemia (Rutherford 3-5) * No untreated inflow-limiting arterial lesions * At least single vessel run-off until the ankle * The patient must be \> 18 years. * Life-expectancy of more than 12 months * The subject or legal guardian has been informed of the nature of the evaluation; agrees to its provisions and has signed informed consent * The patient is capable to follow all evaluation requirements. Exclusion Criteria: * Patient refusing treatment * The reference segment diameter is not suitable for available catheter design * Length of lesion is ≥5 cm or requires more than two overlapping AngioSculpt balloon inflations (whichever is longer) to cover the entire lesion (however, more than two inflations are permitted within an acceptable lesion length) * The 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 * The patient has a history of prior life-threatening contrast media reaction * The patient is currently enrolled in another investigational device or drug trial * The patient is currently breast-feeding, pregnant or intends to become pregnant