GORE VIABAHN ENDOPROSTHESIS Peripheral Vascular Disease Study
Condition: Peripheral Vascular Diseases
MeSH terms: Vascular Diseases; Peripheral Vascular Diseases; Peripheral Arterial Disease
Intervention: GORE VIABAHN Endoprosthesis; Bare Nitinol Stent
Intervention description: Implantation; Implantation
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 148.0
Sex: All
Minimum age: 21 Years
Healthy volunteers: No

Summary:

      To evaluate the performance of the GORE VIABAHN® Endoprosthesis compared to a bare nitinol
      stent for the treatment of superficial femoral artery (SFA) occlusive disease in long
      lesions.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Lifestyle-limiting claudication or rest pain.

          -  Subject (or their legal guardian) has read, understood and provided written informed
             consent.

          -  At least 21 years of age.

          -  Quality of life questionnaires completed.

          -  Noninvasive lower extremity arterial studies within 45-days prior to study procedure.

          -  If applicable, staged ipsilateral vascular procedure ≥ 14-days prior to study
             procedure.

          -  If applicable, vascular treatment on non-study leg for bilateral claudication ≥
             14-days prior to study procedure.

          -  Male, infertile female, or female of child bearing potential practicing an acceptable
             method of birth control with a negative pregnancy test.

          -  Projected life expectancy of greater than three years.

          -  The ability to comply with protocol.

          -  Angiographic and Lesion Requirements meets protocol criteria.

        Exclusion Criteria:

          -  Untreated flow-limiting aortoiliac occlusive disease.

          -  Any previous stenting or surgery in the target vessel.

          -  Subjects with arterial lesions requiring treatment with device diameters other than 6,
             7, or 8 mm.

          -  Severe ipsilateral common femoral/profunda disease requiring surgical intervention.

          -  Femoral or popliteal aneurysm.

          -  Non-atherosclerotic disease resulting in occlusion.

          -  Tibial artery disease requiring treatment.

          -  Prior ipsilateral femoral artery bypass.

          -  Severe medical comorbidities.

          -  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.

          -  Serum creatinine > 2.5 mg/dL within 45 days prior to study procedure.

          -  Major distal amputation.

          -  Septicemia.

          -  Any previously known coagulation disorder.

          -  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.

          -  History of prior life-threatening reaction to contrast agent.

          -  Currently participating in another clinical research trial.

          -  Current peritoneal or hemodialysis.