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CAAAs, TAAAs, Aortic Arch Aneurysms or Dissections With Fenestrated/Branched Stent Graft

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Mar 2027 → Mar 2028
See other at-risk trials from Gustavo S Oderich

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Mar 2027 to Mar 2028
    • Sponsor changed: Baylor College of Medicine to Gustavo S Oderich
    • Site contacts updated at 1 of 3 sites
    • Publications: 41 to 104
    v11
  2. Lead sponsor: Gustavo Oderich to Baylor College of Medicinev10 Show 7 more changesShow less
    • Primary completion date: Mar 2025 to Mar 2027
    • Enrollment target: 530 to 760
    • Study sites: 2 to 3
    • Study completion date: May 2030 to May 2032
    • Interventions: Aortic Arch Aneurysm Arm (Device), Thoracoabdominal Aortic Aneurysm Arm (Device) to Aortic Arch Aneurysm Arm (Device), CAAA and TAAA Arm (Device)
    • Publications: 11 to 41
    • Study title shortened, about 1 word
  3. Site contacts updated at 1 of 2 sitesv9
  4. Enrollment target: 300 to 530
    • Study title shortened, about 8 words
    v8
  5. Lead sponsor: Gustavo S. Oderich to Gustavo Oderichv7 Show 4 more changesShow less
    • Study sites: 1 to 2
    • Eligibility criteria expanded, about 22 words
    • Study description expanded, about 157 words
    • Study title expanded, about 8 words
Show 5 earlier versionsHide 5 earlier versions
  1. Site contact updatedv6
  2. Enrollment target: 200 to 300v5 Show 8 more changesShow less
    • Primary completion date: Mar 2020 to Mar 2025
    • Study completion date: May 2025 to May 2030
    • Interventions: Zenith Fenestrated-Branched System (Device) to Aortic Arch Aneurysm Arm (Device), Thoracoabdominal Aortic Aneurysm Arm (Device)
    • Eligibility criteria expanded, about 742 words
    • Collaborators: 2 to 1
    • Study arms: 1 to 2
    • Study description expanded, about 3 words
    • Study title expanded, about 3 words
  3. Enrollment target: 100 to 200
    • Site contact updated
    • Study title shortened, about 11 words
    v4
  4. Site contact updatedv3
  5. Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    • Collaborators revised (2)
    v2
  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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 purpose of this study is to gather safety and effectiveness of the Zenith t-Branch and customized physician-specified stent-graft with a combination of fenestrations and/or branches to repair aortic aneurysm.
Trial Details
NCT Number NCT02089607
Lead Sponsor Gustavo S Oderich
Collaborators: William Cook Australia
Conditions
(from sponsor)		 Complex Abdominal Aortic Aneurysm, Thoracoabdominal Aortic Aneurysm, Aortic Arch Aneurysm, Aortic Arch Dissection
Related terms Aneurysm, Aneurysm, Aortic Arch, Aortic Aneurysm, Aortic Aneurysm, Thoracoabdominal, Dissection, Thoracic Aorta
Enrollment 760 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov