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The GORE® VIABAHN® FORTEGRA Venous Stent IVC Study

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fieldsv31
  2. Results first posted: Apr 29, 2026
    • Primary completion date: May 27, 2025 to May 9, 2026
    • Primary endpoints: 1 to 2
    • Study completion date: May 2030 to May 9, 2030
    v30
  3. Enrollment target: 112 to 136v29
  4. Primary endpoint revisedv28
  5. Primary completion date changed from estimate of May 2026 to May 27, 2025
    • Secondary endpoints revised (17)
    • Primary endpoint revised
    v27
Show 25 earlier versionsHide 25 earlier versions
  1. Study description expanded, about 8 words
    • Study title expanded, about 1 word
    v26
  2. Re-verified, no change to tracked fieldsv25
  3. Study sites: 21 to 17v24
  4. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 111 to confirmed 112
    • Study sites: 24 to 21
    v23
  5. Trial status: Active, Not Recruiting to Recruiting
    • Study sites: 21 to 24
    v22
  6. Study sites: 23 to 21v21
  7. Primary completion date: Jan 2025 to May 2026
    • Study completion date: Jan 2029 to May 2030
    v20
  8. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 23 of 23 sites
    v19
  9. Study sites: 21 to 23v18
  10. Study sites: 20 to 21v17
  11. Study sites: 19 to 20v16
  12. Study sites: 18 to 19v15
  13. Study sites: 14 to 18v14
  14. Study sites: 13 to 14v13
  15. Study sites: 9 to 13v12
  16. Study sites: 8 to 9v11
  17. Study sites: 6 to 8v10
  18. Study sites: 5 to 6v9
  19. Study sites: 4 to 5v8
  20. Study sites: 3 to 4v7
  21. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 2 to 3
    • Start date changed from estimate of Oct 2022 to Oct 25, 2022
    v6
  22. Study sites: 1 to 2
    • Start date: Sep 2022 to Oct 2022
    v5
  23. Study sites: 0 to 1v4
  24. Start date: Aug 2022 to Sep 2022v3
  25. Start date: Jul 2022 to Aug 2022v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05409976
Lead Sponsor W.L.Gore & Associates
Conditions
(from sponsor)		 Venous Thromboses, Venous Disease, Venous Leg Ulcer, Venous Stasis, Venous Ulcer, Venous Stenosis, Venous Occlusion, Vein Thrombosis +2 more
Related terms Varicose Ulcer, Venous Thrombosis
Enrollment 136 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov