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The GORE® VIABAHN® FORTEGRA Venous Stent Iliofemoral Study

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Aug 2026 → Aug 2027
See other at-risk trials from W.L.Gore & Associates

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Aug 2026 to Aug 2027
    • Enrollment closed, study ongoing
    • Trial sites reduced: 27 → 24 locations
    v21
  2. Primary completion date: Mar 2026 to Aug 2026v20
  3. Study description expanded, about 8 words
    • Study title expanded, about 1 word
    v19
  4. Study sites: 24 to 27v18
  5. Site contacts updated at 1 of 24 sitesv17
Show 15 earlier versionsHide 15 earlier versions
  1. Site contacts updated at 1 of 24 sitesv16
  2. Eligibility criteria expanded, about 80 words
    • Study description revised
    v15
  3. Trial status: Active, Not Recruiting to Recruiting
    • Study sites: 23 to 24
    v14
  4. Primary completion date: Apr 2025 to Mar 2026
    • Study sites: 20 to 23
    • Study completion date: Apr 2029 to Mar 2031
    v13
  5. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 20 of 20 sites
    v12
  6. Study sites: 15 to 20v11
  7. Study sites: 14 to 15v10
  8. Study sites: 12 to 14v9
  9. Study sites: 9 to 12v8
  10. Study sites: 7 to 9v7
  11. Study sites: 4 to 7v6
  12. Study sites: 2 to 4v5
  13. Start date changed from estimate of Mar 2023 to Mar 2, 2023v4
  14. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 2
    • Start date: Feb 2023 to Mar 2023
    v3
  15. Re-verified, no change to tracked fieldsv2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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, 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.
Trial Details
NCT Number NCT05489588
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 165 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov