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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 | Clinical Trials | Clareo Health

RECRUITINGNA

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•W.L.Gore & Associates

View on ClinicalTrials.gov

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

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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.
+5 more criteria

Locations (7)

North Suburban Medical Center

Denver, Colorado, United States

Radiology and Imaging Specialists of Lakeland

Lakeland, Florida, United States

University of Pennsylvania

Philadelphia, Pennsylvania, United States

The University of Texas Southwestern Medical Center

Dallas, Texas, United States

Krankenhaus der Barmherzigen Brüder

Regensburg, Germany

Rijnstate Hospital

Arnhem, Netherlands

Auckland City Hospital

Auckland, New Zealand

Key Dates

Start Date

October 17, 2023

Primary Completion Date

March 30, 2028

Completion Date

January 31, 2032

Last Updated

April 16, 2025

Enrollment

244

ESTIMATED participants

Conditions

Aortoiliac Occlusive DiseasePeripheral Arterial Disease

Interventions

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

Contacts

Makensley Lordeus

CONTACT

623-234-5989 mlordeus@wlgore.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 16, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

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