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Clinical Trials in the UK / NCT05811364
Recruiting Not applicable

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

NCT05811364 · tracked via the Priya Life Science UK tracker
Sponsor
W.L.Gore & Associates
Phase
Not applicable
Started
2023-10-17
Last updated
2026-05-13

Condition(s) studied

Aortoiliac Occlusive DiseasePeripheral Arterial Disease

Investigational drug(s) / intervention(s)

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

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.

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.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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).

Primary outcome measure(s)

Trial sites (43)

FacilityCityRegionStatus
Central Arkansas Veterans Healthcare System Little Rock Arkansas Withdrawn
VA Long Beach Healthcare System Long Beach California Recruiting
Denver Health and Hospital Authority Denver Colorado Recruiting
North Suburban Medical Center Denver Colorado Withdrawn
University of Florida - Gainesville Gainesville Florida Recruiting
Radiology and Imaging Specialists of Lakeland Lakeland Florida Recruiting
University of South Florida Tampa Florida Recruiting
Atlanta VA Medical Center Decatur Georgia Recruiting
Louisiana State University Health Sciences Center New Orleans Louisiana Recruiting
Beth Israel Deaconess Medical Center, Inc. Boston Massachusetts Recruiting
Corewell Health System Grand Rapids Michigan Recruiting
The Curators of the University of Missouri Columbia Missouri Recruiting
Research Foundation SUNY Buffalo Amherst New York Withdrawn
Trinity Medical Center Buffalo New York Recruiting
VA Western New York Healthcare System Buffalo New York Recruiting
New York University School of Medicine New York New York Recruiting
Mt. Sinai Medical Center New York New York Recruiting
Atrium Health Charlotte North Carolina Recruiting
University Hospitals - Cleveland Medical Center Ashland Ohio Recruiting
Cleveland Clinic Foundation Cleveland Ohio Recruiting
Portland Health Care System VA Portland Oregon Recruiting
Providence Heart & Vascular Institute Wilsonville Oregon Recruiting
University of Pennsylvania Philadelphia Pennsylvania Recruiting
Wellmont Holston Valley Medical Center Kingsport Tennessee Recruiting
The University of Texas Southwestern Medical Center Dallas Texas Recruiting
Sentara Medical Group Norfolk Virginia Recruiting
Central Adelaide Local Health Network Incorporated Adelaide Australia Recruiting
Royal Perth Hospital Nedlands Australia Recruiting
Prince of Wales Hospital Randwick Australia Recruiting
Universitats-Herzzentrum Freiburg Bad Krozingen GmbH Bad Krozingen Germany Recruiting
St. Franziskus Hospital Münster Germany Recruiting
Krankenhaus der Barmherzigen Brüder Regensburg Germany Recruiting
Klinikum Stuttgart Stuttgart Germany Recruiting
Ospedale Niguarda Ca'Granda Milan MI Recruiting
Ospedale Santa Maria della Misericordia Perugia Italy Recruiting
Azienda Complesso Ospedaliero San Filippo Neri Roma Italy Recruiting
Ospedale San Giovanni Molinette Turin Italy Recruiting
Rijnstate Hospital Arnhem Netherlands Recruiting
Stichting Elisabeth-TweeSteden Ziekenhuis Tilburg Netherlands Recruiting
Auckland City Hospital Auckland New Zealand Recruiting

+ 3 more sites — see the full list on the official registry below.

More W.L.Gore & Associates trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05811364 on ClinicalTrials.gov ↗ ← All trials in the UK