multi-center study for stent graft system for peripheral artery

Conditions: Peripheral Arterial Disease

Summary: 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.


Eligibility criteria:
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

Keywords: symptomatic pad stenosis occlusion