Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-01-02 @ 6:31 AM
Study NCT ID:
NCT02180958
Status:
COMPLETED
Last Update Posted:
2022-01-31
First Post:
2014-04-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of ONYX in ENDOVASCULAR Treatment of Cerebral AVMs
Sponsor:
Medtronic Neurovascular Clinical Affairs
Organization:
Study Overview
Official Title:
Evaluation of ONYX in ENDOVASCULAR Treatment of Cerebral AVMs. Prospective, Multi-center and Observational French Study
Status:
COMPLETED
Status Verified Date:
2022-01
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:
cAVM
Brief Summary:
To assess safety and efficacy of ONYX treatment for cAVM:
Detailed Description:
The main objective of this study is to assess the safety at 1 month after any embolization session and the efficacy at:
* 12 months post last embolization in case of treatment with embolization only
* 12 months after additional treatment with neurosurgery
* 36 months after additional treatment with radiosurgery
* 12 months post last embolization in case of treatment with embolization only
* 12 months after additional treatment with neurosurgery
* 36 months after additional treatment with radiosurgery
Study Oversight
Has Oversight DMC:
True
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?: