Multi-center Study for Stent Graft System for Peripheral Artery

Exclusion Criteria

• •Untreated flow-limiting aortoiliac disease.
• •Any previous stenting or surgery in the target vessel(i.e. femoro-popliteal artery).
• •Vascular access/catheterization in the target or contralateral limb within 30 days of study enrollment.
• •Planned surgery or intervention within 30 days after study procedure.
• •Femoral artery or popliteal artery aneurysm \> 1.5 X healthy adjacent vessel diameter.
• •Non-atherosclerotic disease resulting in stenosis and/or occlusion (e.g., embolism, Buerger's disease, vasculitis).
• •Severe medical comorbidities (untreated CAD/CHF (Congestive Heart Failure), severe COPD (Chronic Obstructive Pulmonary Disease), severe dementia, NYHA (New York Heart Association) 3/4, severe hypertension, etc.)
• •Any medical condition that would preclude post-procedural ambulation or completion of study follow-up.
• •Rutherford 5 patients with active infection.
• •Serum creatinine \>2.5 mg/dL within 30 days prior to study procedure.
• •Rutherford 6 category in the study or non-study limb or major tissue loss extending above the proximal phalanx level.
• •Rutherford 5 characteristics in non-study limb.
• •Major distal amputation (above the transmetatarsal) in the study or non-study limb.
• •Active infection that could adversely impact patient outcomes in the study, or any patient with septicemia or bacteremia.
• •Any previously known coagulation disorder, including hypercoagulability.
• •Morbid obesity or operative scarring that precludes percutaneous approach
• •Contraindication to anticoagulation or antiplatelet
• •Known allergies to stent/stent-graft components, including heparin sensitivity, allergy, or previous incidence of heparin-induced thrombocytopenia (HIT) type II.
• •Current peritoneal or hemodialysis
• •Participation in another clinical trial (except F/P device clinical trial) up to 3 months prior to study enrollment.
• •Enrollment in a F/P device clinical trial within the last 12 months.
• •Interventional or surgical treatment on arteries distal to the target vessel for this study within the past 12 months.
• •Any other factor identified by the Principal Investigator