SoundBite™ Crossing System Pivotal Peripheral CTO Crossing Study

This is a multinational, single-arm, pivotal trial assessing the efficacy and safety of the SoundBite™ Crossing System - Peripheral. The enrollment will consist of up to 100 patients meeting the inclusion/exclusion criteria in order to obtain 90 evaluable patients for efficacy and safety analysis. The primary endpoints will be compared to literature-based performance goals to establish study success.

Objective Performance Goals (OPG) have been obtained from a literature based review. Reports published in the past 10 years were reviewed for both safety and effectiveness in crossing infrainguinal CTO. The studies reviewed generally have one primary composite safety endpoint and one primary efficacy endpoint. Some studies have performed formal hypothesis testing versus a pre-specified performance goal for one or both endpoints.

General Inclusion Criteria:

• Has symptomatic chronic limb ischemia, requiring treatment of an in:frainguinal artery
• Has Rutherford Clinical Category of 2-5
• Is ≥ 18 years old
• Has life expectancy > 1 year
• Is able and willing to provide written informed consent prior to study procedure

Angiographic Inclusion Criteria:

Unless otherwise specified, the Investigator performing the procedure bases angiographic inclusion on visual determination of qualification imaging taken at time of procedure.

Subject must meet ALL the following angiographic inclusion criteria:

• Has evidence of a clinically significant de novo CTO located in a peripheral vessel below the infrainguinal ligament confirmed by angiography at time of procedure.
• Notwithstanding criteria 1, multilevel CTOs are included as long as the total length from the beginning of the most proximal total occlusion to the end of the most distal total occlusion is less than 40 cm.
• 100% stenosis by visual estimate of angiography at time of procedure.
• Has target limb with at least one patent (<50% stenosis) run-off vessel confirmed by angiography or magnetic resonance angiography at time of procedure.

General Exclusion Criteria:

• Has had a previous peripheral bypass that includes the target vessel.
• Has had a previous intervention on the target CTO (e.g., angioplasty, stent placement), including previous attempt at time of index procedure.
• History of any vascular procedure on the index limb within the last 30 days requiring clinically driven re-intervention.
• Has an active infection in the target limb.
• Subject has any planned major surgical or interventional procedure within 30 days after the study procedure.
• Has received a kidney transplant.
• Glomerular Filtration Rate (GFR) of less than 40.
• Unstable coronary artery disease or other uncontrolled comorbidity.
• Myocardial infarction or stroke within 2 months prior to baseline evaluation.
• Subject has positive pregnancy test result in women of child bearing potential or is breast-feeding.
• Participation in any study of an investigational 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.
• Any thrombolytic therapy within two weeks prior to enrollment.
• Psychiatric disorder which in the judgment of the investigator could interfere with provision of informed consent, completion of tests, therapy, follow-up or general study compliance

Angiographic Exclusion Criteria

Unless otherwise specified, the Investigator performing the procedure bases angiographic exclusion on visual determination of qualification imaging taken up to 6 months prior to procedure and/or imaging taken at time of procedure. Subject is excluded if ANY of the following angiographic exclusion criteria is met:

• Has significant stenos is or occlusion of inflow tract ( upstream disease) unsuccessfully treated at time of index procedure or presenting symptoms such as embolism confirmed by angiography.
• Has in a native vessel, a previously stented segment separated by < 3 cm of angiographically normal vessel from the target CTO.
• CTOs lacking at least one patent target distal artery (::;SO% diameter stenosis).
• Has an acute or sub-acute intraluminal thrombus within the target vessel.
• Aneurysm distal to puncture access site at least twice the reference vessel diameter, located in the index vessel, abdominal aorta, iliac or popliteal.
• Has perforation, dissection or other injury of the access site or index vessel requiring stenting or surgical intervention prior attempting crossing of the target lesion with SoundBite™ Crossing System.
• Clinical/angiographic evidence of distal embolization in the index extremity.