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Ankura™ TAA Stent Graft System Post-Market Clinical Follow-up Study

StatusActive, Not Recruiting
PhaseNot specified
Started
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Record History

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  1. Minor Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 145 to confirmed 147
    • Study sites: 8 to 15
    v9
  2. Minor Study description expanded, about 81 wordsv8
  3. Notable Primary completion date: Dec 30, 2024 to Dec 30, 2026v7 Show 5 more changesShow less
    • Start date: Dec 26, 2022 to May 3, 2023
    • Study sites: 9 to 8
    • Study completion date: Dec 30, 2027 to Dec 30, 2030
    • Interventions: Ankura™ TAA Stent Graft Systems (Device) to Ankura™ TAA Stent Graft System (Device)
    • Study description shortened, about 17 words
  4. Minor Study sites: 8 to 9v6
  5. Minor Site details revised at 1 of 8 sitesv5
Show 3 earlier versionsHide 3 earlier versions
  1. Minor Study sites: 7 to 8v4
  2. Minor Study sites: 8 to 7v3
  3. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Dec 30, 2022 to Dec 26, 2022
    • Site details revised at 8 of 8 sites
    v2
  1. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 collect clinical data on patient outcomes, evaluate the safety and performance of Ankura TAA Stent Graft System and Surpass Super Stiff Guidewire, and build clinical evidence for patients with Descending Thoracic Aneurysm (DTA) or Type B Aortic Dissection (TBAD).
Trial Details
NCT Number NCT05639569
Lead Sponsor Lifetech Scientific (Shenzhen) Co., Ltd.
Conditions
(from sponsor)
Aneurysm Thoracic, Dissection of Thoracic Aorta
Related terms Aortic Aneurysm, Thoracic, Dissection, Thoracic Aorta
Enrollment 147 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov