The DESappear Study: Drug Eluting Scaffold

Inclusion Criteria: Clinical inclusion criteria: 1. Subject is ≥18 years of age. 2. Subject has been informed of the nature of the study, agrees to its provisions, is able to provide informed consent, and agrees to undergo all protocol-required follow up examinations and requirements. 3. Subject's life expectancy is at least 1 year. 4. Subject is diagnosed as having symptomatic claudication (Rutherford-Becker Clinical Category 2-4). 5. For females of childbearing potential, a negative pregnancy test within 14 days before index procedure is required 6. Subject is able to take a P2Y12 receptor antagonist (e.g. clopidogrel, ticagrelor, prasugrel or ticagrelor) and acetylsalicylic acid (aspirin). Angiographic inclusion criteria: 1. A single, de novo native disease segment of the SFA 2. Proximal margin of target lesion is ≥1 cm distal to the common femoral artery bifurcation; distal margin of target lesion is within the SFA. 3. Vessel diameter from ≥5.0 mm to ≤6.0 mm evaluated by on-line quantitative vascular angiography (QVA) after pre-dilatation per core laboratory guidelines. 4. Target lesion diameter reduction ≥50% 5. Target lesion length ≤53 mm 6. Patent inflow artery free from significant lesion (≥50% diameter reduction; 7. Patent distal popliteal artery free from significant lesion (≥50%) with angiographic demonstration of at least one fully patent distal outflow artery (anterior tibial, posterior tibial, or peroneal) to its terminus. Exclusion Criteria: Clinical exclusion criteria: 1. Previous bypass surgery or stenting at the TL; 2. Percutaneous or open surgical revascularization of the contralateral iliac or infrainguinal arteries ≤30 days prior to the planned index procedure. Iliac artery lesions may be treated during the index procedure if necessary for approach to the TL; 3. Failure to successfully cross the target lesion with a guide wire; 4. Subject has a known abdominal aortic aneurysm \>4 cm in diameter, a known iliac artery aneurysm \>3 cm in diameter, or history of open surgical abdominal aortic or iliac revascularization. 5. Lesion within or adjacent to an aneurysm or presence of a popliteal aneurysm; 6. Subject is receiving immunosuppression therapy and has known immunosuppressive or autoimmune disease (e.g. human immunodeficiency virus, systemic lupus erythematosus); 7. Acute limb ischemia; 8. History of a bleeding diathesis; 9. History of a hypercoagulability syndrome; 10. Platelet count \<100,000 cells/mm3 or \>700,000 cells/mm3; a WBC \<3,000 cells/mm3; or hemoglobin \<10.0 g/dL; 11. Acute or chronic renal dysfunction (creatinine \>2.5 mg/dl or \>176 μmol/L), or on chronic hemodialysis; 12. Severe liver impairment as defined by total bilirubin ≥3 mg/dl or two times increase over the normal level of SGOT/AST or SGPT/ALT; 13. Known allergies to the following: aspirin, clopidogrel, prasugrel, ticagrelor, or heparin, contrast agent (that cannot be adequately premedicated), or drugs similar to sirolimus (i.e. tacrolimus, everolimus, zotarolimus) or other macrolides; 14. Subject requires planned procedure within 30 days that would necessitate the discontinuation of clopidogrel, prasugrel, or ticagrelor; 15. Subject is on chronic Coumadin therapy 16. Subject has had or is planned to have treatment with DES or drug coated balloon (DCB) within 90 days pre- or post-index procedure; 17. Subject is non-ambulatory; 18. Subject has undergone percutaneous intervention of the coronary, carotid, or arterial bed exclusive of the \<30 days prior to the planned index procedure. 19. Subject has received, or is on the waiting list for, an organ transplant; 20. Subject had a myocardial infarction (MI) within the previous 30 days prior to the planned index procedure; 21. Subject has had a stroke within the previous 30 days of the planned index procedure and/or has deficits from a prior stroke that limit the subject's ability to walk; 22. Subject has unstable angina defined as rest angina with ECG changes; 23. Subject has a groin infection, or an acute systemic infection that has not been treated successfully or is currently under treatment; 24. Subject has acute thrombophlebitis (superficial or deep) in either extremity; 25. Subject has other medical conditions (e.g., cancer, congestive heart failure or substance abuse) that may cause the subject to be non-compliant with protocol requirements or confound data interpretation; 26. Subject is currently participating or wanting to participate in a clinical trial following 6 months after the index procedure in an investigational drug, biologic, or device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints. (Note: Trials requiring extended follow-up for products that were investigational, but have since become commercially available, are not considered investigational trials); 27. Subject is unable to understand or unwilling to cooperate with study procedures; 28. Subject has prior minor or major amputation of either lower extremity; 29. Subject is part of a vulnerable population who, in the judgment of the investigator, is unable to give informed consent for reasons of incapacity, immaturity, adverse personal circumstances or lack of autonomy; 30. Pre-operative plan for additional treatment of the target lesion at the time of the study procedure with alternative therapy such as drug-eluting stent (DES) and scaffold, laser, atherectomy, cryoplasty, cutting balloon, drug-eluting balloon, or brachytherapy (vessel preparation with uncoated balloon angioplasty is allowed); 31Plan for cardiovascular surgical or interventional procedure ≤30 days after the study procedure including planned treatment of the contralateral lower extremity. Angiographic exclusion criteria: 1. Target extremity has an angiographically significant (\>50% diameter reduction) lesion located in the target vessel distal to the target lesion; 2. Thrombus in the target vessel; 3. Stenosis (\>50%) or occlusion of an ipsilateral inflow artery; 4. Angiographic evidence of thromboembolism or atheroembolism from treatment of an ipsilateral iliac lesion, or from crossing or pre-dilating the target lesion; 5. Target lesion has calcification with either of the following characteristics: * Circumferential orientation, or * Thickness \>2 mm (radially) within the wall of the target lesion. 6. Failure to achieve less than 30% residual stenosis after balloon predilation.