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NEXUS Aortic Arch Clinical Study to Evaluate Safety and Effectiveness

Study acronym: TRIOMPHE
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Jul 2025 to Oct 2025
    • Site contacts updated at 5 of 32 sites
    v31
  2. Primary completion date: Nov 2024 to Jul 2025
    • Study sites: 31 to 32
    v30
  3. Primary completion date: Aug 2024 to Nov 2024v29
  4. Primary completion date: Jun 2023 to Aug 2024
    • Enrollment target: 100 to 110
    • Study sites: 30 to 31
    • Study completion date: Jan 2027 to Oct 2029
    v28
  5. Study sites: 22 to 30v27
Show 25 earlier versionsHide 25 earlier versions
  1. Primary completion date: Feb 2022 to Jun 2023
    • Study sites: 21 to 22
    v26
  2. Site contacts updated at 1 of 21 sitesv25
  3. Study sites: 20 to 21v24
  4. Study sites: 19 to 20v23
  5. Study sites: 18 to 19v22
  6. Study sites: 17 to 18v21
  7. Study sites: 16 to 17v20
  8. Study sites: 17 to 16v19
  9. Study sites: 16 to 17v18
  10. Study sites: 15 to 16v17
  11. Study sites: 14 to 15v16
  12. Study sites: 13 to 14v15
  13. Study sites: 12 to 13v14
  14. Study sites: 11 to 12v13
  15. Study sites: 10 to 11v12
  16. Study sites: 9 to 10v11
  17. Study sites: 8 to 9v10
  18. Study sites: 7 to 8v9
  19. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 5 to 7
    • Start date changed from estimate of Oct 2020 to Oct 20, 2020
    v8
  20. Study sites: 4 to 5v7
  21. Study sites: 3 to 4v6
  22. Study sites: 2 to 3v5
  23. Study sites: 0 to 2v4
  24. Lead sponsor: [Redacted] to Endospan Ltd.v3 Show 5 more changesShow less
    • Trial status: Withheld to Not Yet Recruiting
    • Primary completion date: Feb 2022
    • Study completion date: Jan 2027
    • Start date: Oct 2020
    • Study title shortened, about 3 words
  25. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Prospective, non-randomized, multi-center clinical investigation of the NEXUS™ Aortic Arch Stent Graft System (NEXUSTM) for the treatment of thoracic aortic lesions involving the aortic arch with a proximal landing zone, native or previously implanted surgical graft, in the ascending aorta and with a brachiocephalic trunk native landing zone.
Trial Details
NCT Number NCT04471909
Lead Sponsor Endospan Ltd.
Conditions
(from sponsor)		 Aortic Dissection, Aortic Aneurysm, Intramural Hematoma, Penetrating Aortic Ulcer
Related terms Aortic Aneurysm, Aortic Dissection, Penetrating Atherosclerotic Ulcer
Enrollment 110 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov