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
W.L.Gore & Associates
Summary
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.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DeviceStenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis
Treatment of target lesions in the common and/or external iliac arteries by stenting with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis.
- DeviceStenting of the Common and/or External Iliac Arteries with Bare Metal Stent
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.
Locations (7)
- North Suburban Medical CenterDenver, Colorado
- Radiology and Imaging Specialists of LakelandLakeland, Florida
- University of PennsylvaniaPhiladelphia, Pennsylvania
- The University of Texas Southwestern Medical CenterDallas, Texas
- Krankenhaus der Barmherzigen BrüderRegensburg
- Rijnstate HospitalArnhem