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The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study
NCT05489588 · View on ClinicalTrials.gov ↗
Study Summary
This study is a prospective, non-randomized, multicenter, single-arm, clinical study to evaluate the performance, safety and efficacy of the GORE® VIABAHN® FORTEGRA Venous Stent (formerly known as GORE® VIAFORT Vascular Stent) for treatment of symptomatic iliofemoral venous obstruction.
Conditions Studied
Interventions
- DEVICE GORE® VIAFORT Vascular Stent
Study Locations (20)
New York
- Mount Sinai Medical Center — New York
- Stony Brook — Stony Brook
- St. Peter's Vascular Associates — Troy
North Carolina
- University of North Carolina - Chapel Hill — Chapel Hill
- Atrium Health-Sanger Heart and Vascular Institute — Charlotte
- NC Heart and Vascular Research — Raleigh
Connecticut
- Vascular Care Group — Darien
- Yale University — New Haven
Massachusetts
- Massachusetts General Hospital — Boston
- Vascular Care Group — Wellesley
New Jersey
- Englewood Hospital & Med Center — Englewood
- Holy Name Medical Center — Teaneck
Ohio
- Bethesda North — Cincinnati
- University Hospitals Cleveland — Cleveland
California
- Stanford University School of Medicine — Stanford
Colorado
- Advanced Heart and Vein (ClinRe) — Thornton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 165 participants |
| Start Date | 2023-03-02 |
| Est. Completion | 2031-03 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05489588
The ClinicalTrials.gov registry entry for NCT05489588 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 165 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 10 conditions, with Venous Leg Ulcer appearing as the primary indexed condition, and to 1 intervention — of which GORE® VIAFORT Vascular Stent 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: NCT05489588 reports 20 study locations spanning 12 distinct geographic areas — top geographies include New York, North Carolina, Connecticut. 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 NCT05489588 about?
NCT05489588 is a clinical study titled "The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study". This study is a prospective, non-randomized, multicenter, single-arm, clinical study to evaluate the performance, safety and efficacy of the GORE® VIABAHN® FORTEGRA Venous Stent (formerly known as GORE® VIAFORT Vascular Stent) for treatment of symptomatic iliofemoral venous obstruction.
What is the current status of trial NCT05489588?
This trial is currently recruiting. It is a NA study. The enrollment target is 165 participants. The study started on 2023-03-02. Estimated completion is 2031-03.
What conditions does trial NCT05489588 study?
This clinical trial studies the following conditions: Venous Leg Ulcer, Venous Ulcer, Venous Stasis, Venous Disease, Venous Occlusion. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT05489588?
The interventions under investigation include: GORE® VIAFORT Vascular Stent (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT05489588?
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 NCT05489588 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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