AngioSafe Peripheral CTO Crossing System Study (RESTOR-1 Study)

Inclusion Criteria

• Able and willing to comply with protocol requirements and sign informed consent form
• ≥ 22 years of age
• Peripheral arterial disease defined by Rutherford Clinical Classification (Category 2-5)
• Peripheral artery disease in target extremity is confirmed by imaging (catheter angiography, computed tomographic angiography (CTA), and/or magnetic resonance angiography (MRA))

Angiographic Inclusion Criteria:

• Target lesion in native de novo common femoral artery (CFA), superficial femoral artery (SFA), and/or popliteal artery
• Vessel diameter(s) for target lesion is ≥ 3.0mm and ≤ 10mm
• Subject's target lesion is a severely stenosed segment of ≤ 300 mm that involves the CTO(s)
• Subject's target lesion involves at least one CTO that is 99-100% stenosed
• Subject has at least one vessel with run-off to the foot

Exclusion Criteria

• Systemic infection or an infection in extremity of target lesion
• Target lesion within native vein or synthetic vessel grafts or in stent occlusion
• Planned intervention in the contralateral limb during the study
• Planned intervention in the target limb of the inflow vessels during the study
• Planned intervention of lower extremities after study procedure within 30-day follow-up visit
• Coagulopathy or bleeding diatheses, thrombocytopenia with platelet count less than 50,000/μl, or INR > 1.7
• Antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated
• Allergy to contrast agents or medications used to perform endovascular intervention that cannot be adequately pre-treated
• Allergy to nickel, titanium, urethane, nylon, or silicone
• History of myocardial infarction within 30 days prior to enrollment/consent
• History of stroke within 30 days prior to enrollment/consent
• Chronic kidney disease (CKD) of stage 4 or greater based on an Estimated Glomerular Filtration Rate (eGFR) <30ml/Min, unless the subject is on chronic renal replacement therapy
• Hemoglobin levels <10g/dL verified by a lab test no older than 14 days prior to enrollment, unless the subject has a history of chronic anemia at a stable level, no recent bleeding diathesis or history of blood transfusion in the last six weeks
• Pregnant or nursing, for females of child-bearing potential (< 50 years of age)
• Participating in another interventional research study that may interfere with study endpoints
• Prior major amputation (above ankle) in target extremity
• Acute limb ischemia (ALI)
• Prior unsuccessful attempt to cross the target lesion
• Subject has had a procedure on the target limb or contralateral limb within 7 days
• Subject has had a procedure on the target limb or contralateral limb within the past 30 days and is unstable