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

Inclusion Criteria: * 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). * Patient has at least one sufficient (\<50% stenotic) infrapopliteal run-off vessel. Exclusion Criteria: * 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 …