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Zenith® Fenestrated+ Clinical Study

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Re-verified, no change to tracked fields
  2. Eligibility criteria expanded, about 9 words
    • Site details revised at 6 of 33 sites
  3. Trial status: Active, Not Recruiting to Recruiting
    • Site details revised at 33 of 33 sites
    v40
  4. Re-verified, no change to tracked fieldsv39
  5. Study sites: 32 to 33v38
Show 36 earlier versionsHide 36 earlier versions
  1. Primary completion date: Aug 2026 to Nov 2026
    • Study completion date: Aug 2031 to Nov 2031
    v37
  2. 2 versions Re-verified since Nov 11, 2025, no change to tracked fieldsv35-v36
  3. Enrollment target: 102 to 105
    • Study sites revised (32)
    v34
  4. Study sites revised (32)v33
  5. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date: Jun 2026 to Aug 2026
    • Study completion date: Apr 2031 to Aug 2031
    • Site details revised at 32 of 32 sites
    v32
  6. Site contacts updated at 5 of 32 sitesv31
  7. Study sites: 31 to 32v30
  8. Site details revised at 1 of 31 sitesv29
  9. Study sites: 30 to 31v28
  10. Site details revised at 1 of 30 sitesv27
  11. Site contacts updated at 2 of 30 sitesv26
  12. Study sites: 29 to 30v25
  13. Site contacts updated at 4 of 29 sitesv24
  14. Study sites: 23 to 29v23
  15. Site details revised at 2 of 23 sitesv22
  16. Study sites: 22 to 23v21
  17. Site details revised at 3 of 22 sitesv20
  18. Study sites: 18 to 22v19
  19. Primary completion date: Sep 2025 to Jun 2026
    • Study completion date: Apr 2030 to Apr 2031
    v18
  20. Site details revised at 2 of 18 sitesv17
  21. Site details revised at 5 of 18 sitesv16
  22. Study sites: 11 to 18v15
  23. Study sites: 7 to 11v14
  24. Study sites: 6 to 7v13
  25. Study sites: 3 to 6v12
  26. Study sites: 2 to 3
    • Interventions: Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System (Device) to Zenith Fenestrated+ Endovascular Graft in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System and Unibody2…
    • Eligibility criteria expanded, about 8 words
    v11
  27. Start date changed from estimate of Jan 2024 to Dec 8, 2023v10
  28. Start date: Nov 2023 to Jan 2024
    • Study sites: 1 to 2
    v9
  29. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v8
  30. Start date: Jun 2023 to Nov 2023v7
  31. Re-verified, no change to tracked fieldsv6
  32. Primary completion date: Apr 2024 to Sep 2025
    • Start date: Nov 2022 to Jun 2023
    • Study completion date: Apr 2027 to Apr 2030
    v5
  33. Primary completion date: Aug 2023 to Apr 2024
    • Start date: Feb 2022 to Nov 2022
    • Study completion date: Aug 2027 to Apr 2027
    v4
  34. Start date: Jan 2022 to Feb 2022v3
  35. Start date: Aug 2021 to Jan 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.
The Zenith® Fenestrated+ Endovascular Graft Clinical Study will assess the safety and effectiveness of the Zenith® Fenestrated+ Endovascular Graft (ZFEN+) in combination with the BeGraft Balloon-Expandable FEVAR Bridging Stent Graft System (BeGraft) and Unibody2 for the treatment of patients with aortic aneurysms involving one or more of the major visceral arteries. Up to 130 additional subjects may be enrolled in Continued Access phase of the study
Trial Details
NCT Number NCT04875429
Lead Sponsor Cook Research Incorporated
Conditions
(from sponsor)		 Aortic Aneurysm, Abdominal, Juxtarenal Aortic Aneurysm, Extent IV Thoracoabdominal, Pararenal Aneurysm
Related terms Aortic Aneurysm, Abdominal, Cardiovascular Diseases, Vascular Diseases
Enrollment 105 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov