W.L.Gore & Associates
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.
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…
Treatment of target lesions in the common and/or external iliac arteries by stenting with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis.
Treatment 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.