IMPRoving Outcomes in Vascular DisEase - Aortic Dissection

Study acronym: IMPROVE-AD
StatusRecruiting
PhaseNot applicable
Started

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Record History

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  1. Minor Trial sites expanded: 63 → 66 locations
    • Eligibility criteria expanded, about 12 words
    • Secondary endpoints: details revised at 6 of 14 entries
  2. Minor Study sites: 62 to 63v12
  3. Minor Study sites: 60 to 62
    • Eligibility criteria shortened, about 2 words
    v11
  4. Minor Study sites: 57 to 60
    • Secondary endpoints: 16 to 14
    • Eligibility criteria expanded, about 5 words
    v10
  5. Minor Study sites: 33 to 57v9
Show 7 earlier versionsHide 7 earlier versions
  1. Minor Re-verified, no change to tracked fieldsv8
  2. Minor Study sites: 15 to 33
    • Eligibility criteria expanded, about 2 words
    v7
  3. Minor Primary completion date: Jun 2030 to Jun 1, 2030
    • Study completion date: Jun 2030 to Jun 30, 2030
    v6
  4. Minor Study sites: 1 to 15
    • Start date changed from estimate of Jun 30, 2024 to Apr 14, 2024
    v5
  5. Notable Trial status: Not Yet Recruiting to Recruiting
    • Start date: Feb 2024 to Jun 30, 2024
    • Study sites: 0 to 1
    v4
  6. Notable Start date: Dec 2023 to Feb 2024v3
  7. Minor Re-verified, no change to tracked fieldsv2
  1. Minor Study First Submitted
  • 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.
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The goal of this clinical trial is to determine whether an upfront invasive strategy of TEVAR plus medical therapy reduces the occurrence of a composite endpoint of all-cause death or major aortic complications compared to an upfront conservative strategy of medical therapy with surveillance for deterioration in patients with uncomplicated type B aortic dissection.
Trial Details
NCT Number NCT06087029
Lead Sponsor Duke University
Collaborators: The University of Texas Health Science Center, Houston, State University of New York - Downstate Medical Center, Oregon Health and Science University, National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)
Type B Aortic Dissection
Enrollment 1,100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov