RecruitingAortoiliac Occlusive DiseasePeripheral Arterial Disease

The GORE VBX FORWARD Clinical Study: A Comparison of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis to Bare Metal Stenting for Patients With Complex Iliac Occlusive Disease

Eligible age

18+ yrs

Accepts

All genders

Locations

17 states

Healthy volunteers

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About this study

The objective of this prospective, multicenter, randomized, controlled clinical trial is to demonstrate the superiority of the VBX Device for primary patency when compared to bare metal stenting in complex iliac occlusive disease.

Sponsor: W.L.Gore & Associates

You may qualify if…

✓ Age ≥ 18 years at time of informed consent signature
✓ Informed Consent Form (ICF) is signed by the subject
✓ Subject can comply with protocol requirements, including follow-up
✓ Patient has symptomatic claudication, rest pain, or minor tissue loss (Rutherford Category 2-5)
✓ Patient has de novo or restenotic lesion(s) found in the common and/or external iliac artery(ies)
✓ Patient has: Unilateral or bilateral single or multiple lesions (\>50% stenosis or chronic total occlusion) each between 4 and 11 cm in length
✓ Patient has a target vessel diameter visually estimated to be approximately between 5 mm and 13 mm
✓ Patient has a sufficient (\<50% stenotic) common femoral artery and at least one sufficient (\<50% stenotic) femoral artery (deep or superficial).

You may not qualify if…

✕ Life expectancy \<1 year
✕ Patient is pregnant at time of informed consent.
✕ Patient has a known allergy to stent or stent graft components (including nitinol, stainless steel, or heparin).
✕ Patient has severe chronic renal insufficiency (serum creatinine level \> 2.5mg/dL) and not undergoing hemodialysis.
✕ Patient has evidence of a systemic infection.
✕ Patient has a known intolerance to antithrombotic medications that prevent compliance with study or control device Instructions for Use.
✕ Patient has had vascular catheterization of the lower extremities within 30 days of randomization (excluding diagnostic angiograms for the study procedure).
✕ Patient has previous stenting in the iliac arteries.