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

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 medications used during or subsequent to endovascular intervention. Patients with aspirin allergy that have been desensitized are not excluded.
• •History of heparin-induced thrombocytopenia (HIT) that cannot be treated with direct thrombin inhibitors.
• •Psychiatric disorder which in the judgment of the investigator could interfere with provision of informed consent, completion of tests, therapy or general study compliance.
• •The target CTO is located \< 3 cm from a stented segment.
• •Has an acute or sub-acute intraluminal thrombus within the target vessel.
• •Clinical/ angiographic evidence of distal embolization in the index extremity unresolved prior to crossing.