Prospective Study of the SoundBite™ Crossing System in Complex Peripheral CTOs

Inclusion Criteria: General Inclusion Criteria * Has symptomatic non-acute limb ischemia, requiring treatment of an infrainguinal artery * Has Rutherford Clinical Category of 2-6 * is able and willing to provide written informed consent prior to study procedure Angiographic Inclusion Criteria * 100% stenosis by a visual estimate of angiography at the time of the procedure * target CTO has moderate to severe calcification * Has at least one of the following: severe calcification, flush occlusion, femoropopliteal CTOs with reconstitution below Popliteal 2-3, side directing collateral at the proximal cap, long (≥ 5cm) occlusions, below the knee (BTK) occlusion. * Has evidence of a clinically significant CTO located in a peripheral vessel below the infrainguinal ligament confirmed by angiography at time of the procedure. Exclusion Criteria: General Exclusion Criteria * Insufficient kidney function or renal failure * Subject has positive pregnancy test result * Participation in any study of a study device, medication, biologic, or other agent during study or within 30 days prior to enrollment that is either a cardiovascular study or could, in the judgment of the investigator, affect the results of this study * Subject in whom antiplatelet, anticoagulant therapy is contraindicated * Uncorrectable bleeding diathesis, platelet dysfunction, thrombocytopenia with platelet count less than 100,000/ml or known coagulopathy * Known, untreated allergy to contrast agents or medication…