IRB Study Number 23-809
Status Recruiting
Location Cleveland Clinic Main Campus
Institute Heart and Vascular Institute
Description
The Gore VBX study is intended to demonstrate the superiority of the VBX Device for primary patency when compared to bare metal stenting in complex iliac occlusive disease. The study is randomized 1:1 to the VBX group (GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis) or to the control group (bare metal stenting).
Inclusion Criteria
- Patient has symptomatic claudication, rest pain, or minor tissue loss (Rutherford Categories 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
- Patient has a lesion requiring drug-coated balloon angioplasty, atherectomy, lithotripsy, or any ablative device to facilitate stent delivery
- Patient has an abdominal aortic artery occlusion or aneurysm
- Patient has isolated common iliac artery stenosis that can be treated with a single device (i.e., common iliac artery stenosis that does not require kissing stents or extended into the external iliac artery)
- Patient has outflow disease that requires concomitant interventions (i.e., common femoral endarterectomy or femoral / tibial revascularization)
