Home › Trials › NCT05811364

Comparison of a new endoprosthesis to traditional stenting for iliac artery disease

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

NA · W.L.Gore & Associates · NCT05811364

This study is testing a new type of stent for people with iliac artery disease to see if it works better than the traditional metal stents in improving blood flow and relieving symptoms.

Quick facts

PhaseNA
Study typeInterventional
Enrollment244 (estimated)
Ages18 Years and up
SexAll
SponsorW.L.Gore & Associates (industry)
Locations43 sites (Little Rock, Arkansas and 42 other locations)
Trial IDNCT05811364 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to compare the effectiveness of the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis against traditional bare metal stenting in patients suffering from complex iliac occlusive disease. It is a multicenter, randomized, controlled trial designed to demonstrate the superiority of the VBX device in achieving primary patency. Eligible participants will include those with symptomatic claudication or other related conditions and specific lesion characteristics in their iliac arteries. The study will assess outcomes related to blood flow restoration and symptom relief.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older with symptomatic claudication or related conditions and specific lesions in their iliac arteries.

Not a fit: Patients with a life expectancy of less than one year or those who are pregnant will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a more effective treatment option for patients with complex iliac occlusive disease, potentially improving their quality of life.

How similar studies have performed: Other studies have shown promising results with similar endoprosthesis approaches, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion 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).

Where this trial is running

Little Rock, Arkansas and 42 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Aortoiliac Occlusive Disease, Peripheral Arterial Disease

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.