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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

NCT05811364 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2026-05-13

No results posted yet for this 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.

Conditions

  • Aortoiliac Occlusive Disease
  • Peripheral Arterial Disease

Interventions

DEVICE

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.

DEVICE

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.

Sponsors & Collaborators

  • W.L.Gore & Associates

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-17
Primary Completion
2028-03-30
Completion
2032-01-31
FDA Device
Yes

Countries

  • United States
  • Australia
  • Germany
  • Italy
  • Netherlands
  • New Zealand
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05811364 on ClinicalTrials.gov