NCT04999423

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 206 (actual)
• Sponsor: Microvention-Terumo, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed 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

Conditions

• Intracranial Aneurysm

Interventions

Type	Name	Description
DEVICE	LVIS EVO and HydroCoil Embolic System	Stent assisted Coiling

Timeline

• Start date: 2022-01-14
• Primary completion: 2025-03-01
• Completion: 2026-12-01
• First posted: 2021-08-10
• Last updated: 2025-01-07

Locations

19 sites across 5 countries: Belgium, France, Germany, Italy, United Kingdom