Multi-center Study for Stent Graft System for Peripheral Artery

The Utility of GP1101 Relative to Surgical Bypass in the Treatment of Femoral / Popliteal Arterial Symptomatic Peripheral Arterial Disease

The utility of GP1101 will be evaluated relative to that of surgical bypass in the treatment of Femoral/Popliteal Arterial Symptomatic Peripheral Arterial Disease. Efficacy will be measured by comparison to a Surgical Bypass Efficacy Goal, and Invasiveness will be measured by comparison to Surgical Bypass data derived from a retrospective study.

Inclusion Criteria:

• Rutherford 2-5 category
• Subject has read, understood and signed written informed consent which has been reviewed and approved by the Institutional Review Board (IRB).
• At least 20 years of age.
• Ankle-brachial index (ABI) in the study limb in the non-invasive lower extremity arterial studies within 30 days prior to study procedure or at the time of study procedure is less than or equal to 0.9, or toe-brachial index (TBI) is less than or equal to 0.5.
• Male, infertile female, or female of child-bearing potential practicing an acceptable method of birth control with a negative pregnancy test within 7 days prior to study procedure.
• Projected life expectancy of greater than 2 years.
• The ability to comply with the study protocol, follow-up requirements and required testing.
• Surgical bypass candidate
• Qualifying lesions by angiography

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