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NCT05409976 · ClinicalTrials.gov registry record · NA
The GORE® VIABAHN® FORTEGRA Venous Stent IVC Study
A NA study of Venous Leg Ulcer and Venous Ulcer, sponsored by W.L.Gore & Associates.
- Active
- Registry status
- NA
- Development phase
- 112
- Enrollment target
- 17
- Study locations
NCT05409976: Active NA study of Venous Leg Ulcer and Venous Ulcer, sponsored by W.L.Gore & Associates.
NCT05409976 is a NA study of Venous Leg Ulcer and Venous Ulcer that is active but no longer recruiting, run by W.L.Gore & Associates. The registered enrollment target is 112 participants, below the 242-participant average among 35 other Venous Leg Ulcer trials with a reported enrollment target (54% lower). The trial reports 17 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05409976, a NA study of Venous Leg Ulcer and Venous Ulcer, is active but no longer recruiting, sponsored by W.L.Gore & Associates.
- ACTIVE NOT RECRUITING
- Registry status
- NA
- Development phase
- 112 participants
- Enrollment target
- 17
- Study locations
Study Summary
This study is a prospective, multicenter, non-randomized, single-arm 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 inferior vena cava obstruction with or without combined iliofemoral obstruction in adult patients.
Primary Outcome
Composite primary endpoint consisting of freedom from the following: * Loss of primary patency through 12-month follow-up * 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 throug
Conditions Studied
Interventions
- DEVICE GORE® VIAFORT Vascular Stent
Study Locations (17)
Other
- Universitätsklinikum Aachen - Aachen
- Alexianer Klinikum Hochsauerland GmbH - Arnsberg
- Ospedale San Raffaele - Milan
- Hesperia Hospital - Modena
- Auckland City Hospital - Auckland
- Addenbrooke's Hospital - Cambridge
- St Thomas' Hospital - London
New York
- Mount Sinai Medical Center - New York
- Weill Cornell Medical College - New York
California
- Stanford University School of Medicine - Stanford
District of Columbia
- MedStar Washington Hospital Center - Washington D.C.
Illinois
- Northwestern - Chicago
Michigan
- University of Michigan - Ann Arbor
North Carolina
- Atrium Health-Sanger Heart and Vascular Institute - Charlotte
Virginia
- Sentara - Norfolk
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2022-10-25 |
| Est. Completion | 2030-05 |
| Phase | NA |
What the registry record for NCT05409976 still lists
NCT05409976 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 242-participant average among 35 other Venous Leg Ulcer trials with a reported enrollment target (54% 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.
NCT05409976 lists 17 locations in 10 states (Other, New York, California).
Frequently Asked Questions
What is clinical trial NCT05409976 about?
NCT05409976 is a clinical study titled "The GORE® VIABAHN® FORTEGRA Venous Stent IVC Study". This study is a prospective, multicenter, non-randomized, single-arm 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 inferior vena cava obstruction with or without combin...
What is the current status of trial NCT05409976?
This trial is currently active not recruiting. It is a NA study. The enrollment target is 112 participants. The study started on 2022-10-25. Estimated completion is 2030-05.
What conditions does trial NCT05409976 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 NCT05409976?
The interventions under investigation include: GORE® VIAFORT Vascular Stent (DEVICE).
Who is sponsoring clinical trial NCT05409976?
This trial is sponsored by W.L.Gore & Associates, which has 53 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05409976 being conducted?
This trial has 17 study locations across California, District of Columbia, Illinois, Michigan, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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112 24th of 35 higher than 12 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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