Natural Vascular Scaffold (NVS) Therapy

Inclusion Criteria: * Subject is at least 18 years of age. * Subject (or legal guardian) understands the study requirements and the treatment procedure and provides written informed consent before any study-specific tests or procedures are performed. * Subject is eligible for PTA. * Subject is willing to comply with all protocol required follow-up evaluations. * Subject has documented Rutherford Classification 2 to 4 (see Appendix 3). * Subject has laboratory test results that are within clinically acceptable limits. * In Investigator's opinion, subject is hemodynamically stable at the time of the index procedure. * Subject has a life expectancy of ≥1 year in the opinion of the Investigator. Exclusion Criteria: * Subject had cerebrovascular accident (CVA) or transient ischemic attack (TIA) within the past 3 months prior to enrollment. * Subject has any permanent neurologic defect that may cause non-compliance with the protocol. * Subject had an MI within last the 3 months prior to enrollment. * Subject is pregnant, planning to become pregnant, breastfeeding or planning to breastfeed in the next 365 days. * Subject is currently receiving oral or intravenous immunosuppressive therapy (ie, inhaled steroids are not excluded). * Subject has known life-limiting immunosuppressive or autoimmune disease (eg, human immunodeficiency virus, systemic lupus erythematosus, but not including diabetes mellitus). * Subject has local or systemic thrombolytic therapy within 48 hours prior to index procedure. * Subject is currently on oral anticoagulation therapy, such as warfarin, rivaroxaban, apixaban, or dabigatran etexilate. * Subject has known allergies or sensitivities to heparin, aspirin (ASA), or other anticoagulant/antiplatelet therapies. * Subject has an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure. * Subject has an active peptic ulcer or active gastrointestinal (GI) bleeding. * Subject has documented or suspected liver disease, including laboratory evidence of hepatitis. * Subject has renal failure or chronic kidney disease with glomerular filtration rate (GFR) ≤ 30 mL/min or Modification of Diet in Renal Disease (MDRD) study equation result of ≤ 30 mL/min per 1.73 m2. * Subject has white blood cell (WBC) count \< (3,000 cells/mm3) within 7 days prior to index procedure. * Subject has a platelet count \< 100,000 cells/mm3 or \> 700,000 cells/mm3 ≤ 7 days pre-procedure. * Subject has been diagnosed with bleeding diatheses or hypercoagulable state. * Subject has known or suspected active systemic infection evidenced by WBC \> 14.0 (14,000/mm3). * Subject is currently participating in another investigational drug or device study. * Subject intends to participate in another investigational drug or device study within 365 days after the index procedure. * Subject has any surgical procedure or intervention performed within the 30-day period prior to index procedure.