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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

Sponsor: W.L.Gore & Associates

NCT ID: NCT05811364

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis (device), Stenting of the Common and/or External Iliac Arteries with Bare Metal Stent (device)
How long the study runs
Study runs about 99 months (dates as stated)
About the drug or intervention
Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis — device: Treatment of target lesions in the common and/or external iliac arteries by stenting with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis. · Stenting of the Common and/or External Iliac Arteries with Bare Metal Stent — device: 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.
Patient visit burden
Not specified by the sponsor

In plain English

This study compares two ways of treating blocked or narrowed iliac arteries (the large arteries in the pelvis that carry blood to the legs) in people with aortoiliac occlusive disease, a type of peripheral arterial disease. One group will receive the GORE VIABAHN VBX Balloon Expandable Endoprosthesis (a stent covered with fabric, expanded by a balloon), and the other group will receive a bare metal stent (an uncovered metal mesh tube). The study is funded by W.L. Gore & Associates.

Who can take part

  • Adults aged 18 or over who give informed consent
  • Have leg symptoms such as pain when walking (claudication), rest pain, or minor tissue loss
  • Have a narrowing (more than 50%) or complete blockage in the common or external iliac artery that is between 4 and 11 cm long
  • The artery to be treated is roughly between 5 mm and 13 mm wide
  • The arteries further down the leg are mostly clear (less than 50% narrowed), including at least one artery below the knee
  • Able to attend follow-up appointments and follow the study requirements

Who may not be able to

  • Expected to live less than 1 year
  • Pregnant at the time of consent
  • Allergic to stent materials (including nitinol, stainless steel, or heparin)
  • Severe kidney problems (high creatinine) if not on dialysis
  • Signs of a body-wide infection
  • Cannot take blood-thinning medicines as required
  • Had a leg artery procedure (catheterisation) in the last 30 days, apart from the study's own diagnostic scans
  • Already has a stent in the iliac arteries or has had bypass surgery on the same leg
  • Taking part in another clinical study, unless the sponsor approves in writing
  • The blockage needs treatment with a drug-coated balloon, atherectomy, lithotripsy, or other devices that remove plaque
  • Has a problem or bulge (aneurysm) in the abdominal aorta
  • Needs a stent placed within 2 cm of the groin ligament
  • Has a simple blockage in one common iliac artery that could be treated with a single device
  • Needs other procedures at the same time, such as surgery on the groin or leg arteries

What taking part involves

  • • Placement of either the GORE VIABAHN VBX covered stent graft or a bare metal stent in the narrowed or blocked iliac artery
  • • Follow-up visits as set out in the study plan — details not stated, ask the trial team

Time commitment: Taking part involves the stenting procedure and follow-up visits; the number of visits and total study duration are not stated — ask the trial team.

Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.

Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
244
Started
2023-10-17
Last checked
2026-05

Plain English Summary

What is this study?

  • • Testing a new treatment for aortoiliac occlusive disease
  • • NA - 244 participants
  • • 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

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with aortoiliac occlusive disease

Where?

  • • Canterbury - East Kent Hospitals University NHS Foundation Trust
  • • London - Guy's and St Thomas', NHS Foundation Trust
  • • Southampton - University Hospital Southampton NHS Foundation Trust

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

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.

Aortoiliac Occlusive DiseasePeripheral Arterial Disease

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Age ≥ 18 years at time of agreement to take part signature
  • ✓agreement to take part Form (ICF) is signed by the subject
  • ✓Subject can comply with protocol requirements, including follow-up
  • ✓Patient has causing symptoms 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)

Who cannot take part

  • ✗Life expectancy \<1 year
  • ✗Patient is pregnant at time of agreement to take part.
  • ✗Patient has a known allergy to stent or stent graft components (including nitinol, stainless steel, or heparin).
  • ✗Patient has severe chronic kidney insufficiency (kidney blood test level \> 2.5mg/dL) and not undergoing hemodialysis.
  • ✗Patient has evidence of a systemic infection.
See the 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).

Where Is This Study? (3 UK sites)

East Kent Hospitals University NHS Foundation Trust

Canterbury, United Kingdom

Recruiting
Hospital R&D contact (matched)

Caroline Cowley, Research & Innovation/Clinical Trials Unit Manager

ekhuft.researchandinnovation@nhs.net01227 783169

Guy's and St Thomas', NHS Foundation Trust

London, United Kingdom

Recruiting
Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

University Hospital Southampton NHS Foundation Trust

Southampton, United Kingdom

Recruiting
Hospital R&D contact (matched)

Dr Mikayala King

researchmanagement@uhs.nhs.uk023 81208215

How to Get in Touch

Alexander Ambrocik

Sponsor contact

CONTACT

337-387-4954 aambroc@wlgore.com

Enoque Costa

Sponsor contact

CONTACT

928-525-4044 ecosta@wlgore.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-05