Evaluation of the 25 Centimeter (cm) GORE® VIABAHN® Endoprosthesis

Study Overview
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Brief Summary
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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.

Official Title
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Evaluation of the 25 Centimeter (cm) GORE® VIABAHN® Endoprosthesis With PROPATEN Bioactive Surface to Treat de Novo and/or Restenotic Lesions of the Superficial Femoral Artery (SFA)

Conditions
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Peripheral Vascular Diseases

Intervention / Treatment
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* Device: 25 cm GORE® VIABAHN®


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 25cm Gore VIABAHN<br>25 cm GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface | Device: 25 cm GORE® VIABAHN®<br>* 25 cm GORE® VIABAHN® Endoprosthesis with PROPATEN Bioactive Surface, possibly in conjunction with an additional overlapping VIABAHN® device (2.5, 5, 10, 15, or 25 cm lengths) based on the enrolled patient's lesion length (greater than or equal to 20 cm length).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful Completion of the Assigned Treatment | Successful completion of the assigned treatment and postdeployment> stent length (of the first deployed 25 cm GORE> VIABAHN Endoprosthesis with PROPATEN Bioactive Surface)> being within 10% of pre-deployment stent length. | Evaluated immediately after the index procedure | 
| Device-related and Procedure-related Serious Adverse Events (SAEs) Within 30 Days of the Index Procedure |  | 30 Days post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stent-graft, superficial femoral artery, SFA, peripheral artery disease, PAD