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NCT05489588 · ClinicalTrials.gov registry record · NA
The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study
A NA study of Venous Leg Ulcer and Venous Ulcer, sponsored by W.L.Gore & Associates.
- Recruiting
- Registry status
- NA
- Development phase
- 165
- Enrollment target
- 20
- Study locations
NCT05489588: Recruiting NA study of Venous Leg Ulcer and Venous Ulcer, sponsored by W.L.Gore & Associates.
NCT05489588 is a NA study of Venous Leg Ulcer and Venous Ulcer that is actively recruiting participants, run by W.L.Gore & Associates. The registered enrollment target is 165 participants, below the 240-participant average among 35 other Venous Leg Ulcer trials with a reported enrollment target (31% lower). The trial reports 20 study locations across 12 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05489588, a NA study of Venous Leg Ulcer and Venous Ulcer, is actively recruiting participants, sponsored by W.L.Gore & Associates.
- RECRUITING
- Registry status
- NA
- Development phase
- 165 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Composite primary safety endpoint consisting of freedom from the following: * Stent embolization through 12-month follow-up * Device- or procedure-related death through 30 days * Clinically significant pulmonary embolism confirmed via Computed Tomography Angiography through 30 days * Device- or procedure-related vascular injury through 30 days requiring surgical or endovascular intervention * Device- or procedure-related major bleeding events through 30 day
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 |
What NCT05489588 shows while recruiting
NCT05489588 is an interventional study that assigns participants to a tested intervention. The registered 165 participants enrollment target is mid-sized for trials with a published cap, below the 240-participant average among 35 other Venous Leg Ulcer trials with a reported enrollment target (31% lower).
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.
NCT05489588 names 20 study sites across 12 states, led by New York, North Carolina, Connecticut.
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.
What interventions are being tested in trial NCT05489588?
The interventions under investigation include: GORE® VIAFORT Vascular Stent (DEVICE).
Who is sponsoring clinical trial NCT05489588?
This trial is sponsored by W.L.Gore & Associates, which has 53 total clinical trials registered on ClinicalTrials.gov.
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.
Learn More About Clinical Trials
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Where NCT05489588's enrollment target sits among peer trials
165 15th of 35 higher than 20 of 35 other Venous Leg Ulcer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Venous Leg Ulcer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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