evaluation of the 25 centimeter (cm) gore® viabahn® endoprosthesis

Conditions: Peripheral Vascular Diseases

Summary: the purpose of this study is to confirm the safety and performance of the 25 cm gore® viabahn® endoprosthesis with propaten bioactive surface when used in the superficial femoral artery.


Eligibility criteria:
inclusion criteria: * lifestyle-limiting claudication or rest pain (meeting angiographic entry criteria) affecting a lower extremity (rutherford categories 2-4). * a written informed consent form, which has been reviewed and approved by the ethics committee, has been read, understood and signed by the subject (or their legally authorized representative). * at least 21 years of age. * noninvasive lower extremity arterial studies (ankle-brachial index, abi) prior to (within 45 days) or at the time of the study procedure demonstrating a resting ankle-brachial index (abi) ≤ 0.9 in the study limb. if abi \> 0.9, patient is eligible for study if toe-brachial index (tbi) is ≤ 0.5. * a staged ipsilateral vascular procedure was not completed less than 30-days prior to the study procedure. resting abis were completed prior to the study procedure a minimum of 30-days after the staged vascular procedure. * vascular treatment on the non-study leg for bilateral claudication was not performed less than 30-days prior to study procedure. resting abis on the study limb were completed prior to the study procedure a minimum of 30-days after treatment on the non-study leg. * 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 three years. * the ability to comply with protocol follow-up requirements and required testing. * angiographic and lesion requirements (assessed intraoperatively): * lesion length of 20-35 cm located in the region beginning 1 cm below origin of the profunda femoris artery and ending 1 cm above the origin of the intercondylar fossa. * de novo, post-percutaneous transluminal angioplasty (pta), or post-atherectomy stenosis (\> 50% at some point within the lesion by visual estimate) or occlusion of native sfa. * origin and proximal 1 cm of sfa are patent. * popliteal artery is patent from 1 cm above the origin of the intercondylar fossa distal to the radiographic knee joint. * reference vessel diameter of 4.0 - 7.5 mm in proximal and distal treatment segments within the sfa. * angiographic evidence of at least one patent tibial artery to the ankle that does not require intervention. * guidewire has successfully traversed lesion and is within the true lumen of the distal vessel. exclusion criteria: * untreated flow-limiting aortoiliac occlusive disease. * any previous open surgical procedure in the target vessel or previous stent placement in the target vessel. * prior angioplasty on the target lesion performed less than 30 days prior to the study procedure (unless performed at time of the study procedure). * prior atherectomy on the target lesion performed less than 6 months prior to the study procedure (unless performed at time of the study procedure). * any previous treatment of the target vessel with a drug-eluting balloon. * femoral artery or popliteal artery aneurysm. * non-atherosclerotic disease resulting in occlusion (e.g. embolism, buerger's disease, vasculitis). * tibial artery disease requiring treatment. * prior ipsilateral femoral artery bypass. * severe medical comorbidities (untreated coronary artery disease, congestive heart failure, severe chronic obstructive pulmonary disease, metastatic malignancy, dementia, etc.) or other medical condition that would preclude post-procedural ambulation. * popliteal artery vascular access at any time during procedure. * antegrade and retrograde vascular access on the same common femoral artery at the time of the sfa intervention. * major distal amputation (above the transmetatarsal) in the study or non-study limb. * septicemia. * any previously known coagulation disorder, including hypercoagulability. * morbid obesity or operative scarring that precludes percutaneous approach (physician's discretion). * contraindication to anticoagulation or antiplatelet therapy. * known allergies to stent/stent-graft components, including heparin sensitivity, allergy, or previous incidence of heparin-induced thrombocytopenia (hit) type ii. * history of prior life-threatening reaction to contrast agent. * currently participating in another clinical research trial, unless approved by w. l. gore \& associates in advance of study enrollment. * subject has one limb currently enrolled in the study. * current peritoneal or hemodialysis.

Keywords: stent-graft superficial femoral artery sfa peripheral artery disease pad