NCT05811364 · W.L.Gore & Associates
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
What this study is about
The objective of this forward-looking, conducted at multiple hospitals, randomly assigned, 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.
View original scientific description
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.
Interventions
DEVICE
Stenting 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.
DEVICE
Stenting 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.
Primary outcome measures
Primary Patency
Time frame: 1 year
Blood flow through the target lesion (no evidence of binary restenosis \>50% or occlusion) without a Target Lesion Revascularization (TLR).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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).
Where
- Little Rock, Arkansas
- Long Beach, California
- Denver, Colorado
- Gainesville, Florida
- Lakeland, Florida
- Tampa, Florida
- Decatur, Georgia
- New Orleans, Louisiana
- Boston, Massachusetts
- Grand Rapids, Michigan
- Columbia, Missouri
- Amherst, New York
And 11 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 13, 2026 · Source of record for eligibility and locations