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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 · View on ClinicalTrials.gov ↗
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 Studied
Interventions
- DEVICE 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
Study Locations (7)
Other
- Krankenhaus der Barmherzigen Brüder — Regensburg
- Rijnstate Hospital — Arnhem
- Auckland City Hospital — Auckland
Colorado
- North Suburban Medical Center — Denver
Florida
- Radiology and Imaging Specialists of Lakeland — Lakeland
Pennsylvania
- University of Pennsylvania — Philadelphia
Texas
- The University of Texas Southwestern Medical Center — Dallas
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 244 participants |
| Start Date | 2023-10-17 |
| Est. Completion | 2032-01-31 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05811364
The ClinicalTrials.gov registry entry for NCT05811364 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 244 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is W.L.Gore & Associates, which has 117 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Peripheral Arterial Disease appearing as the primary indexed condition, and to 2 interventions — of which Stenting of the Common and/or External Iliac Arteries with the GORE® VIABAHN® VBX Balloon Expandable Endoprosthesis is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT05811364 reports 7 study locations spanning 5 distinct geographic areas — top geographies include Other, Colorado, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT05811364 about?
NCT05811364 is a clinical study titled "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". 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.
What is the current status of trial NCT05811364?
This trial is currently recruiting. It is a NA study. The enrollment target is 244 participants. The study started on 2023-10-17. Estimated completion is 2032-01-31.
What conditions does trial NCT05811364 study?
This clinical trial studies the following conditions: Peripheral Arterial Disease, Aortoiliac Occlusive Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05811364?
The interventions under investigation include: 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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05811364?
This trial is sponsored by W.L.Gore & Associates, which has 117 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT05811364 being conducted?
This trial has 7 study locations across Colorado, Florida, Pennsylvania, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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