Ignite Creation Date:
2024-05-06 @ 4:27 PM
Last Modification Date:
2024-10-26 @ 2:11 PM
Study NCT ID:
NCT04999423
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-01-23
First Post:
2021-07-28
Brief Title:
LVIS Evo and HydroCoil Embolic System for Intracranial Aneurysm Treatment
Sponsor:
Microvention-Terumo Inc
Organization:
Microvention-Terumo Inc
Study Overview
Official Title:
Safety and Effectiveness Analysis of Stent Assisted Coiling With LVIS Evo and HydroCoil Embolic System in Aneurysm Treatment
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SEALANT
Brief 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
Sample size 200 patients
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None