Recruiting

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 · NCT05811364

Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation: Not posted. Ask the study team before screening.
Who can join: Ages 18+ · All sexes
Healthy volunteers: Not accepted (a condition is required)
Study type: Interventional · Not applicable
Target enrollment: 244
US sites recruiting: 23
Study start: October 17, 2023
Record last updated: May 13, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis; Stenting of the Common and/or External Iliac Arteries with Bare Metal Stent

Conditions: Aortoiliac Occlusive Disease; Peripheral Arterial Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

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 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

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).

Recruiting US locations

VA Long Beach Healthcare System
Long Beach, CA 90822
Site contact: Anthony Chau, MD
Denver Health and Hospital Authority
Denver, CO 80204
Site contact: Lisa Bennett, MD
University of Florida - Gainesville
Gainesville, FL 32608
Site contact: Samir Shah, MD
Radiology and Imaging Specialists of Lakeland
Lakeland, FL 33801
Site contact: Fakhir Elmasri, MD
University of South Florida
Tampa, FL 33620
Site contact: Sashi Inkollu, MD
Atlanta VA Medical Center
Decatur, GA 30033
Site contact: Olamine Alabi, MD
Louisiana State University Health Sciences Center
New Orleans, LA 70112
Site contact: Malachi Sheahan, MD
Beth Israel Deaconess Medical Center, Inc.
Boston, MA 02215
Site contact: Mark Wyers, MD
Corewell Health System
Grand Rapids, MI 49503
Site contact: Andrew Kimball, MD
The Curators of the University of Missouri
Columbia, MO 65212
Site contact: Jonathan Bath, MD
Trinity Medical Center
Buffalo, NY 14214
Site contact: Aimee Swartz, MD
VA Western New York Healthcare System
Buffalo, NY 14215
Site contact: Hasan Dosluoglu, MD
New York University School of Medicine
New York, NY 10016
Site contact: Karan Garg, MD
Mt. Sinai Medical Center
New York, NY 10029
Site contact: Prakash Krishnan, MD
Atrium Health
Charlotte, NC 28210
Site contact: Hector Crespo-Soto, MD
University Hospitals - Cleveland Medical Center
Ashland, OH 44805
Site contact: Yulanka Castro-Dominguez, MD
Cleveland Clinic Foundation
Cleveland, OH 44195
Site contact: Levester Kirksey, MD
Portland Health Care System VA
Portland, OR 97239
Site contact: Harish Krishnamoorthi, MD
Providence Heart & Vascular Institute
Wilsonville, OR 97070
Site contact: Brant Ullery, MD
University of Pennsylvania
Philadelphia, PA 19104
Site contact: Grace Wang, MD
Wellmont Holston Valley Medical Center
Kingsport, TN 37660
Site contact: Christopher Metzger, MD
The University of Texas Southwestern Medical Center
Dallas, TX 75390
Site contact: Melissa Kirkwood, MD
Sentara Medical Group
Norfolk, VA 23507
Site contact: David Dexter, MD

Study contacts (from the official record)

Alexander Ambrocik · 337-387-4954 · aambroc@wlgore.com
Enoque Costa · 928-525-4044 · ecosta@wlgore.com