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LVIS™ Evo™ and HydroCoil® Embolic System for Intracranial Aneurysm Treatment

Study acronym: SEALANT
StatusActive, Not Recruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated January 7, 2025 (before its estimated March 1, 2025 completion). Its status may not reflect the trial's current state.

Record History

See every version on ClinicalTrials.gov ↗

  1. Primary completion date: Dec 1, 2024 to Mar 1, 2025v7
  2. Trial status: Recruiting to Active, Not Recruiting
    • Enrollment target: estimated 200 to confirmed 206
    • Site details revised at 19 of 19 sites
    v6
  3. Study sites: 6 to 19v5
  4. Study sites: 4 to 6
    • Eligibility criteria revised
    • Study title revised
    v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 4
    • Start date changed from estimate of Jan 30, 2022 to Jan 14, 2022
    v3
  6. Start date: Sep 30, 2021 to Jan 30, 2022v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 is a prospective multicenter international single-arm observational study to demonstrate that use of stent-assisted coiling with LVIS™ Evo™ and HydroCoil® Embolic System (HES) in intracranial aneurysm treatment is effective and safe when assessed at 1 year after the procedure
Trial Details
NCT Number NCT04999423
Lead Sponsor Microvention-Terumo, Inc.
Conditions
(from sponsor)		 Intracranial Aneurysm
Related terms Aneurysm, Intracranial Aneurysm
Enrollment 206 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov