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Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms With Surpass Elite With GUARDian Flow Diverter (GUARD)

Study acronym: GUARD
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Trial sites expanded: 3 → 10 locationsv5
  2. Trial status: Active, Not Recruiting to Recruiting
    • Primary completion date: Mar 31, 2028 to Jan 31, 2029
    • Study completion date: Mar 31, 2028 to Jan 31, 2031
    • Site details revised at 3 of 3 sites
    v4
  3. Trial status: Recruiting to Active, Not Recruiting
    • Study sites: 2 to 3
    • Eligibility criteria expanded, about 39 words
    • Secondary endpoints: 6 to 7
    v3
  4. Lead sponsor: [Redacted] to Stryker Neurovascularv2 Show 4 more changesShow less
    • Trial status: Withheld to Recruiting
    • Primary and study completion dates: Mar 31, 2028
    • Start date: Jun 20, 2025
    • Study title expanded, about 4 words
  5. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 objective of the Safety and Efficacy of Endovascular Treatment of Intracranial Aneurysms with Surpass Elite with GUARDian Flow Diverter (GUARD) trial is to evaluate the safety and efficacy of the Surpass Elite with Guardian Flow Diverter System (FDS) in the treatment of unruptured, wide-neck saccular or fusiform, intracranial aneurysms (IAs) located on the internal carotid artery (ICA) or its branches.
Trial Details
NCT Number NCT06872684
Lead Sponsor Stryker Neurovascular
Conditions
(from sponsor)		 Aneurysm, Aneurysm, Intracranial
Related terms Aneurysm, Intracranial Aneurysm
Enrollment 183 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov