Clinical Trials Logo
  1. Home
  2. Intracranial Aneurysm
  3. NCT04999423

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
See also
  Status Clinical Trial Phase
Recruiting NCT04870047 - Coating to Optimize Aneurysm Treatment In The New Flow Diverter Generation N/A
Completed NCT05968053 - Detection of Microplastics and Nanoplastics in Neurosurgery Patients (DT-MiNi)
Not yet recruiting NCT05665309 - Interest of Pre-operative Use of 3D Printing for Endovascular Treatment of Unruptured Intracranial Aneurysms With Intrasaccular Flow Disruptor N/A
Completed NCT02783339 - Neuroform Atlas Stent for Intracranial Aneurysm Treatment
Withdrawn NCT01194388 - Axium Coil in Completing Endovascular Aneurysm Surgery Study
Completed NCT00071565 - Familial Intracranial Aneurysm Study II N/A
Recruiting NCT05409989 - MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED™ X™) Post-Approval Study N/A
Completed NCT03680742 - Contour Neurovascular System - European Pre-Market Unruptured Aneurysm N/A
Completed NCT04872842 - Establishment of Online Registration Platform for Unruptured Intracranial Aneurysms Based on 100 Regional Medical Centers in China and Population Follow-up Study
Terminated NCT02532517 - Study to Evaluate the Safety and Effectiveness of the CODMAN ENTERPRISE® Vascular Reconstruction Device N/A
Completed NCT03663257 - Study to Evaluate Cerebral AneurysmFlow Results in Occlusion
Recruiting NCT06189950 - Registration Trial of the Intracranial Visualized Stent for the Wide-necked Intracranial Aneurysms:REBRIDGE N/A
Recruiting NCT05608122 - Establishment of Online Registration Platform for Unruptured Intracranial Aneurysms Based on Regional Medical Centers in China and Population Follow-up Study (Phase Ⅱ)
Recruiting NCT03661463 - Unruptured Intracranial Aneurysm Aspirin Trial (UIAAT). Phase 2
Completed NCT02609867 - A Feasibility Study to Evaluate the Safety and Effectiveness of Implantation of Flowise Cerebral Flow Diverter (Flowise) N/A
Active, not recruiting NCT02292017 - Prospective Packing Density With Target Coils I N/A
Active, not recruiting NCT01872741 - Minipterional Versus Pterional Craniotomy N/A
Completed NCT00993057 - Efficiency of Two Glucose Sampling Protocols for Maintenance of Euglycemia Early Phase 1
Completed NCT00777088 - Pipeline for Uncoilable or Failed Aneurysms N/A
Completed NCT00777907 - Complete Occlusion of Coilable Aneurysms Phase 3