Back to search results

GORE VBX FORWARD Study for Iliac Artery Disease

This study is comparing two ways to treat complex iliac occlusive disease (a condition where blood flow to your legs is blocked): the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis and a standard bare metal stent. Researchers want to see if the GORE® VIABAHN® VBX device keeps arteries open longer. You might be able to join if you are at least 18 years old, have symptoms like leg pain when walking or at rest, and have blockages in your common or external iliac arteries. The main goal is to see how well the arteries stay open after one year. The current recruitment status is unclear.

Study design
This is a randomized, controlled study comparing two different stenting devices. It plans to enroll 244 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for at least one year to check if their arteries remain open.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05811364

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
NAAges 18+InterventionalTreatment
W.L.Gore & Associates
~244 participants
Updated 2026-05-13 on ClinicalTrials.gov
What's tested:Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable EndoprosthesisStenting of the Common and/or External Iliac Arteries with Bare Metal Stent

At a glance

Recruiting sites
40 of 43 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Primary Patency
Measured over 1 year

Conditions

Aortoiliac Occlusive Disease
Peripheral Arterial Disease

Explore related trials

Arterial occlusive diseasePeripheral Artery Disease

Where it's being run

43 sites across 24 states
New York5
Germany4
Florida3
Australia3
Italy3
United Kingdom3
Colorado2
Ohio2

Who to contact

Alexander Ambrocik
[email protected]
337-387-4954
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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).

What this trial measures

  • Primary Patency1 year

    Blood flow through the target lesion (no evidence of binary restenosis \>50% or occlusion) without a Target Lesion Revascularization (TLR).