GORE VIABAHN ENDOPROSTHESIS Peripheral Vascular Disease Study

W.L. Gore & Associates

Status and phase

Completed

Phase 4

Conditions

Peripheral Vascular Diseases

Treatments

Device: GORE VIABAHN Endoprosthesis

Device: Bare Nitinol Stent

Study type

Interventional

Funder types

Industry

Identifiers

NCT00228384

SFA 05-03

Details and patient eligibility

About

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.

Full description

This is a multicenter, prospective, randomized study with clinical and radiographic follow-up for three years post-procedure. Approximately one hundred fifty subjects will be enrolled and randomized into one of two study treatment groups.

Enrollment

148 patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

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.