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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
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
Where Is This Study? (3 UK sites)
East Kent Hospitals University NHS Foundation Trust
Canterbury, United Kingdom
Caroline Cowley, Research & Innovation/Clinical Trials Unit Manager
ekhuft.researchandinnovation@nhs.net01227 783169Guy's and St Thomas', NHS Foundation Trust
London, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, United Kingdom
How to Get in Touch
Alexander Ambrocik
Sponsor contactCONTACT
Enoque Costa
Sponsor contactCONTACT
