A Prospective, Multi-Center, Non-Randomized, Single-Arm Study of the BDTM Low Profile Vascular Covered Stent in Peripheral Artery Disease (AGILITY)

The objective of this study is to assess the safety and effectiveness of the BD™LPVCS for the treatment of stenosis and occlusion in the common and/or external iliac artery and the superficial femoral artery (SFA)/proximal popliteal artery (PPA).

This is a prospective, multi-center, non-randomized, single-arm study designed to assess the safety and effectiveness of the BD™ LPVCS for the treatment of stenosis and occlusion in the common and/or external iliac artery and SFA/PPA. The study will consist of two cohorts with separate primary endpoints and analysis time points for the iliac artery (primary endpoint at 9 months) and the SFA/PPA (primary endpoint at 12 months).

Clinical Inclusion Criteria To be eligible to participate in this study, a subject must meet all of the following criteria: 1. The subject provides written informed consent using an Informed Consent Form (ICF) that is reviewed and approved by the Ethics Committee (EC) / Institutional Review Board (IRB) for the site. 2. The subject agrees to comply with the protocol-mandated follow-up procedures and visits. 3. The subject is a male or non-pregnant female ≥ 21 years old with an expected lifespan sufficient to allow for completion of all study procedures. Female subjects of childbearing potential must have a negative pregnancy test (urine or blood) prior to the index procedure. 4. The subject is able and willing to comply with any required medication regimen. Clinical Exclusion Criteria Subjects are excluded from the study if any of the following criteria apply: 1. The subject suffered a hemorrhagic stroke or transient ischemic attack (TIA) within three (3) months prior to the index procedure. 2. The subject has a known, uncorrectable bleeding diathesis or active coagulopathy or severe thrombocytopenia (platelet count < 80,000/μL). 3. The subject has serum creatinine ≥ 2.5 mg/dl or is currently on dialysis. 4. The subject has a known allergy or sensitivity to Tantalum and Nitinol (i.e., Nickel, Titanium), ePTFE, or has intolerance to the antiplatelet, anticoagulant, or thrombolytic medications required per the protocol. 5. The subject has a known allergy or sensitivity to contrast media, which cannot be adequately pre-medicated. 6. The subject has another medical condition, which, in the opinion of the Investigator, may cause him/her to be non-compliant with the protocol, confound the data interpretation, or is associated with a life expectancy insufficient to allow for the completion of study procedures and follow-up. 7. The subject is currently participating in an investigational drug, biologic, or device study. Studies requiring extended follow-up for products that are now commercially available are not considered investigational studies. . The subject requires a concomitant surgical procedure (e.g., endarterectomy followed by stenting). 9. A non-index procedure planned intervention within 30 days of the index procedure or a planned intervention 30 days post-index procedure. 10. Prior or planned major amputation (of either limb)

Primary Endpoints (with Hypothesis Testing) The primary endpoint for each of the cohorts will be evaluated against literature-based Performance Goals (PGs). Iliac Cohort: A composite safety and effectiveness measure defined as device and/or procedure-related death or myocardial infarction (MI) through 30 days, or clinically driven target lesion revascularization (CD-TLR), or target limb major amputation (at or above the ankle), or target lesion restenosis through 9 months post-index procedure. SFA/PPA Cohort: Primary Safety: Freedom from Major Adverse Events (MAEs) through 30 days, defined as the following: All cause death • Target limb major amputation (at or above the ankle) • CD-TLR Primary Effectiveness: Primary Patency at 12 months.