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 (catheterangiography, computed tomographic angiography (CTA), and/or magnetic resonanceangiography (MRA))

Angiographic Inclusion Criteria:

• Target lesion in native de novo common femoral artery (CFA), superficial femoralartery (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 theCTO(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-dayfollow-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 interventionthat 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 GlomerularFiltration Rate (eGFR) <30ml/Min, unless the subject is on chronic renal replacementtherapy

• Hemoglobin levels <10g/dL verified by a lab test no older than 14 days prior toenrollment, unless the subject has a history of chronic anemia at a stable level, norecent 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 studyendpoints

• 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