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Hemiarch vs Extended Arch in Type 1 Aortic Dissection

Study acronym: HEADSTART
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Study sites: 4 to 5
    • Eligibility criteria shortened, about 6 words
    • Secondary endpoints: details revised at 2 of 6 entries
    • Publications: details revised at 1 of 1 entry
  2. Lead sponsor: University of Calgary to Ottawa Heart Institute Research Corporationv3 Show 4 more changesShow less
    • Enrollment target: 182 to 50
    • Primary and study completion dates: Mar 31, 2025 to Mar 31, 2027
    • Start date changed from estimate of May 15, 2019 to Jul 30, 2024
    • Study sites revised (4)
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Apr 1, 2019 to May 15, 2019
    • Site details revised at 4 of 4 sites
    v2
  4. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
HEADSTART is a prospective, open-label, non-blinded, multicenter, randomized controlled trial that compares a composite of mortality and re-intervention in patients undergoing hemiarch and extended arch repair for acute DeBakey type 1 aortic dissection. Eligible patients will be randomized to one or the other surgical strategy and clinical and imaging outcome data will be collected over a 3 year follow up period.
Trial Details
NCT Number NCT03885635
Lead Sponsor Ottawa Heart Institute Research Corporation
Conditions
(from sponsor)		 Aortic Dissection
Related terms Aortic Dissection
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov