Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-31 @ 1:45 AM
Study NCT ID:
NCT01975233
Status:
COMPLETED
Last Update Posted:
2023-01-26
First Post:
2013-10-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
WEB French Observatory of the WEB Aneurysm Embolization System
Sponsor:
Microvention-Terumo, Inc.
Organization:
Study Overview
Official Title:
WEB French Observatory
Status:
COMPLETED
Status Verified Date:
2023-01
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:
None
Brief Summary:
An observational post-market, open label, multicenter Observatory. The decision to use a WEB device to treat the patients has been made before and independently of the decision to include the patient in the French Observatory.
Detailed Description:
Subjects will be screened for Observatory eligibility after giving informed consent. The embolization procedure will be performed in the digital angiographic suite using standard angiographic techniques.
Initial analysis of Observatory data will be performed at completion of 12 month follow-up for the first thirty-five (35) subjects.
Subjects will be followed per Institution's standard of care.
Initial analysis of Observatory data will be performed at completion of 12 month follow-up for the first thirty-five (35) subjects.
Subjects will be followed per Institution's standard of care.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: