SELUTION4SFA Trial

Eligibility Criteria

• 1. Subject age is ≥ 18 years or minimum legal age as required by local regulations.
• 2. Life expectancy \>1 year in opinion of investigator.
• 3. Documented ischemia with Rutherford classification category 2, 3 or 4.
• 4. Target lesion(s) in the SFA or PPA.
• 5. Able to walk without the assistance of a walker.
• 6. Subject is willing and able to provide informed consent and comply with study procedures and required follow-up evaluations.
• 7. Female subjects only: If female, then subjects of childbearing potential must have a negative pregnancy test ≤ 7 days before the procedure and be prepared to use effective contraception for 12 months after treatment.
• 1. Other surgical or endovascular procedure in the target limb that occurred within 14 days prior to index procedure or is planned for within 30 days following index procedure, with exception for diagnostic angiography.
• 2. Inability to tolerate dual antiplatelet therapy.
• 3. Known hypersensitivity or allergy to Sirolimus or other pharmacologic agents, such as contrast agent, which are required for the procedure and which cannot be adequately pre-treated.
• 4. Stroke or MI within 3 months of enrollment.
• 5. Symptom onset less than 14 days prior to index procedure (acute limb ischemia).
• 6. Lower limb disease in the contralateral leg that requires treatment at the index procedure, or, that is planned within 14 days prior to the index procedure or within 30 days after the index procedure.
• 7. Prior vascular surgery (including bypass and endarterectomy) of abdominal aorta, iliac arteries, or arteries of the index limb.
• 8. Non-atherosclerotic disease of the index limb (including aneurysmal disease, vasculitis, Buerger's disease)
• 9. Target lesion requires treatment with alternative therapies such as thrombolysis, thrombus aspiration, cutting/scoring/contoured balloon, stenting, laser, cryoplasty, intravascular lithotripsy, brachytherapy, re-entry device).
• 10. Subject has target lesion(s) that require treatment via pedal site.
• 11. Subject has target lesion(s) that require access via upper extremity arteries.
• 12. Hypercoagulable state or disorder present, or coagulopathy present, including platelet count less than 80,000 per microliter.
• 13. Chronic renal insufficiency (dialysis dependent, or serum creatinine \>2.5 mg/dL within 30 days of index procedure).
• 14. Systemic infection (WBC \> 12,000 and febrile) or known immune compromise.
• 15. Breast-feeding woman.
• 16. Currently participating in another investigational drug or device study that has not completed primary endpoint follow-up.