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.