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Assessment of the GORE® EXCLUDER® Conformable AAA Endoprosthesis in the Treatment of Abdominal Aortic Aneurysms

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. 2 versions Re-verified since Dec 5, 2024, no change to tracked fieldsv16-v17
  2. Results first posted: Apr 4, 2024v15 Show 5 more changesShow less
    • Primary endpoints revised (2)
    • Study sites: 45 to 51
    • Primary completion date changed from estimate of Aug 15, 2027 to May 25, 2023
    • Secondary endpoints: 23 to 24
    • Study description expanded, about 1 word
  3. Primary completion date: Dec 30, 2022 to Aug 15, 2027v14 Show 4 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 190 to confirmed 175
    • Study sites: 50 to 45
    • Study completion date: Dec 31, 2026 to Dec 31, 2027
  4. Secondary endpoints: details revised at 23 of 23 entries
    • Site details revised at 2 of 50 sites
    v13
  5. Primary completion date: Sep 30, 2021 to Dec 30, 2022v12
Show 10 earlier versionsHide 10 earlier versions
  1. Primary completion date: Mar 2021 to Sep 30, 2021
    • Study completion date: Dec 2024 to Dec 31, 2026
    • Site details revised at 3 of 50 sites
    v11
  2. Primary completion date: Dec 2020 to Mar 2021v10
  3. Study sites: 5 to 50v9
  4. Study sites: 3 to 5v8
  5. Trial status: Not Yet Recruiting to Recruitingv7 Show 4 more changesShow less
    • Study sites: 0 to 3
    • Primary completion date: Oct 2020 to Dec 2020
    • Study completion date: Oct 2024 to Dec 2024
    • Start date changed from estimate of Oct 2017 to Dec 19, 2017
  6. Primary completion date: Mar 2020 to Oct 2020
    • Start date: Mar 2017 to Oct 2017
    • Study completion date: Mar 2024 to Oct 2024
    v6
  7. Start date: Nov 2016 to Mar 2017
    • Primary completion date: Nov 2019 to Mar 2020
    • Study completion date: Nov 2023 to Mar 2024
    v5
  8. Study description shortened, about 5 wordsv4
  9. Primary completion date: Mar 2017 to Nov 2019
    • Start date: Sep 2015 to Nov 2016
    • Study completion date: Sep 2022 to Nov 2023
    • Study description revised
    v3
  10. Enrollment target: 80 to 190v2 Show 4 more changesShow less
    • Eligibility criteria shortened, about 27 words
    • Study description expanded, about 6 words
    • Study arms: 1 to 2
    • Study title shortened, about 3 words
  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 the study is to assess the safety and effectiveness of the GORE® EXCLUDER® Conformable AAA Endoprosthesis to treat an infrarenal aneurysm located in the abdominal aorta. Performance of the GORE® EXCLUDER® Conformable AAA Endoprosthesis will be judged by separate performance goals.
Trial Details
NCT Number NCT02489539
Lead Sponsor W.L.Gore & Associates
Conditions
(from sponsor)		 Aortic Aneurysm, Abdominal
Related terms Aneurysm, Aortic Aneurysm, Aortic Aneurysm, Abdominal, Cardiovascular Diseases, Vascular Diseases
Enrollment 175 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov