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

Intracranial Aneurysm Clinical Trial

Official title:
Safety and Effectiveness Analysis of Stent Assisted Coiling With LVIS™ Evo™ and HydroCoil® Embolic System in Aneurysm Treatment

Clinical Trial 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

Clinical Trial Description

Patient treatment and follow-up will be performed as per standard of care. The study will evaluate the proportion of aneurysms with complete occlusion based on Raymond-Roy occlusion classification (RROC) at 12 ± 6-months, as well as other effectiveness and safety endpoints such as the occurence of stent stenosis or parent artery occlusion, the occurence of retreatment and recanalization, the rate of major ipsilateral stroke or neurological death, the proportion of patients with good functional clinical outcome, the occurence of SAH, aneurysm rupture, procedural complications, serious adverse events... Sample size: 200 patients ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04999423
Study type Observational
Source Microvention-Terumo, Inc.
Contact
Status Active, not recruiting
Phase
Start date January 14, 2022
Completion date December 1, 2026
View Details
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