Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-02-27 @ 11:05 AM
Study NCT ID:
NCT03844334
Status:
COMPLETED
Last Update Posted:
2024-01-24
First Post:
2019-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms
Sponsor:
Microvention-Terumo, Inc.
Organization:
Study Overview
Official Title:
CLEVER: CLinical EValuation of WEB 0.017 Device in Intracranial AneuRysms
Status:
COMPLETED
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:
CLEVER
Brief Summary:
The study is an observational, European, multi-center, prospective assessment of the clinical utility of the 0.017 WEB Aneurysm Embolization System in subjects with intracranial aneurysms deemed appropriate for endovascular treatment.
Detailed Description:
All eligible subjects presenting to the participating Centers will be considered for entry into the study. Up to 160 evaluable subjects meeting the study entry criteria will be enrolled.
Subjects will be followed per Institution's standard of care.
Subjects will be followed per Institution's standard of care.
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?: