Clinical Trial

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

Study acronym: SEALANT
Active, Not Recruiting
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.
Summary
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
Protocol Amendment History 6 amendments
This ClinicalTrials.gov record has been amended 6 times since 2021-08-03; most recent amendment 2025-01-06.
Status change: Recruiting → Active, Not Recruiting 2024-01-22
Status change: Not Yet Recruiting → Recruiting 2022-01-19
Trial Details
NCT Number NCT04999423
Lead Sponsor Microvention-Terumo, Inc.
Conditions Intracranial Aneurysm
Enrollment 206 participants
Start Date 2022-01-14
Primary Completion 2025-03-01 (estimated)
Study Completion 2026-12-01 (estimated)
Updated on ClinicalTrials.gov 2025-01-07