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Study of the RelayPro Thoracic Stent-Graft in Subjects With an Acute, Complicated Type B Aortic Dissection

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Study completion date: Oct 2026 to Nov 2026v10
  2. Study sites: 32 to 21
    • Primary completion date changed from estimate of Mar 31, 2024 to Oct 31, 2021
    • Study completion date: Mar 31, 2027 to Oct 2026
    v9
  3. Re-verified, no change to tracked fieldsv8
  4. Primary completion date: Mar 31, 2022 to Mar 31, 2024
    • Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 80 to confirmed 56
    • Study sites: 38 to 32
    v7
  5. Re-verified, no change to tracked fieldsv6
Show 4 earlier versionsHide 4 earlier versions
  1. Primary completion date: May 17, 2019 to Mar 31, 2022
    • Study sites: 22 to 38
    • Study completion date: Apr 17, 2024 to Mar 31, 2027
    v5
  2. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Mar 17, 2017 to Dec 14, 2017
    • Study sites: 0 to 22
    • Eligibility criteria shortened, about 26 words
    v4
  3. Re-verified, no change to tracked fieldsv3
  4. Eligibility criteria expanded, about 7 words
    • Secondary endpoints revised (3)
    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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This clinical trial is a prospective, multicenter, non-blinded, non-randomized study designed to assess the RelayPro thoracic endografts in the treatment of acute, complicated type B aortic dissection. The primary endpoint will measure all-cause mortality at 30 days post-procedure.
Trial Details
NCT Number NCT03033043
Lead Sponsor Bolton Medical
Conditions
(from sponsor)		 Aortic Dissection Type B
Enrollment 56 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov