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