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

Recruiting now · Not applicable

Conditions studied: Aortoiliac Occlusive Disease, Peripheral Arterial Disease

In brief

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.

Key facts

Study ID

NCT05811364

Run by

W.L.Gore & Associates

People needed

244

Starts

2023-10-17

Expected to finish

2032-01-31

Last updated by the study team

2026-05-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 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.

You may not qualify if…

• 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.
• Patient has evidence of a systemic infection.
• Patient has a known intolerance to antithrombotic medications that prevent compliance with study or control device Instructions for Use.
• Patient has had vascular catheterization of the lower extremities within 30 days of randomization (excluding diagnostic angiograms for the study procedure).
• Patient has previous stenting in the iliac arteries.
• Patient has previous surgical bypass in the target limb.
• Patient is currently participating in another investigative clinical study unless received written approval by the sponsor.
• 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 lesion or aneurysm.
• Patient has a lesion that requires stent placement within 2 cm of the inguinal ligament.
• 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 extend into the external iliac artery).
• Patient has outflow disease that requires concomitant interventions (i.e. common femoral endarterectomy or femoral / tibial revascularization).

Where it is running

• University Hospital Southampton NHS Foundation Trust — Southampton, United Kingdom (enrolling)
• VA Long Beach Healthcare System — Long Beach, California, United States (enrolling)
• Denver Health and Hospital Authority — Denver, Colorado, United States (enrolling)
• Auckland City Hospital — Auckland, New Zealand (enrolling)
• East Kent Hospitals University NHS Foundation Trust — Canterbury, United Kingdom (enrolling)
• Guy's and St Thomas', NHS Foundation Trust — London, United Kingdom (enrolling)
• University of Florida - Gainesville — Gainesville, Florida, United States (enrolling)
• Radiology and Imaging Specialists of Lakeland — Lakeland, Florida, United States (enrolling)
• University of South Florida — Tampa, Florida, United States (enrolling)
• Atlanta VA Medical Center — Decatur, Georgia, United States (enrolling)
• Louisiana State University Health Sciences Center — New Orleans, Louisiana, United States (enrolling)
• Beth Israel Deaconess Medical Center, Inc. — Boston, Massachusetts, United States (enrolling)
• Corewell Health System — Grand Rapids, Michigan, United States (enrolling)
• The Curators of the University of Missouri — Columbia, Missouri, United States (enrolling)
• Trinity Medical Center — Buffalo, New York, United States (enrolling)
• VA Western New York Healthcare System — Buffalo, New York, United States (enrolling)
• New York University School of Medicine — New York, New York, United States (enrolling)
• Mt. Sinai Medical Center — New York, New York, United States (enrolling)
• Atrium Health — Charlotte, North Carolina, United States (enrolling)
• University Hospitals - Cleveland Medical Center — Ashland, Ohio, United States (enrolling)
• Cleveland Clinic Foundation — Cleveland, Ohio, United States (enrolling)
• Portland Health Care System VA — Portland, Oregon, United States (enrolling)
• Providence Heart & Vascular Institute — Wilsonville, Oregon, United States (enrolling)
• University of Pennsylvania — Philadelphia, Pennsylvania, United States (enrolling)
• Wellmont Holston Valley Medical Center — Kingsport, Tennessee, United States (enrolling)

Full record on ClinicalTrials.gov

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