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PERSEVERE- A Trial to Evaluate AMDS in Acute DeBakey Type I Dissection

Study acronym: PERSEVERE
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status: Recruiting to Active, Not Recruitingv13 Show 4 more changesShow less
    • Enrollment target: estimated 133 to confirmed 115
    • Study sites: 26 to 25
    • Study completion date: Jul 2029 to Dec 6, 2029
    • Publications: details revised at 1 of 3 entries
  2. Trial status: Active, Not Recruiting to Recruitingv12 Show 4 more changesShow less
    • Enrollment target: 93 to 133
    • Primary completion date: Nov 6, 2023 to Dec 11, 2023
    • Study completion date: Mar 2028 to Jul 2029
    • Site details revised at 26 of 26 sites
  3. Primary endpoints revised (2)v11
  4. Trial status: Recruiting to Active, Not Recruiting
    • Primary completion date changed from estimate of Mar 2024 to Nov 6, 2023
    • Site details revised at 26 of 26 sites
    v10
  5. Study sites revised (26)v9
Show 7 earlier versionsHide 7 earlier versions
  1. Study sites: 25 to 26v8
  2. Study sites: 20 to 25v7
  3. Study sites: 14 to 20v6
  4. Study sites: 5 to 14v5
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 5
    • Start date changed from estimate of May 2022 to May 27, 2022
    v4
  6. Lead sponsor: CryoLife, Inc. to Artivion Inc.
    • Start date: Jan 2022 to May 2022
    • Eligibility criteria expanded, about 1 word
    v3
  7. Primary endpoints 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Prospective, non-randomized, multicenter clinical investigation to assess the safety and effectiveness of AMDS in the treatment of patients with acute DeBakey type I dissection, with evidence of malperfusion, through open surgical repair.
Trial Details
NCT Number NCT05174767
Lead Sponsor Artivion Inc.
Collaborators: Syneos Health
Conditions
(from sponsor)		 Acute Aortic Dissection
Related terms Aortic Diseases, Aortic Dissection, Cardiovascular Diseases
Enrollment 115 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov