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.
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)
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.
Parallel
Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
DeviceTreatment of target lesions in the common and/or external iliac arteries by stenting with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis.
Stenting of the Common and/or External Iliac Arteries with Bare Metal Stent
DeviceTreatment of target lesions in the common and/or external iliac arteries by stenting with a commercially available bare metal stent that is approved for treatment of the disease.
Primary Patency
Blood flow through the target lesion (no evidence of binary restenosis \>50% or occlusion) without a Target Lesion Revascularization (TLR).
Technical success
Deployment of device with \< 30% residual stenosis on final angiography.
Acute procedural success
Binary assessment based on technical success and freedom from device or procedure-related serious adverse events (SAE) requiring intervention.
Clinical success
Improvement from baseline of at least 1 Rutherford Category and freedom from device or procedure-related SAE requiring intervention.
Hemodynamic Status
Change in Ankle-brachial index (ABI)/toe-brachial index (TBI) as compared to baseline
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