Ignite Creation Date:
2024-05-05 @ 10:48 PM
Last Modification Date:
2024-10-26 @ 10:24 AM
Study NCT ID:
NCT01194388
Status:
WITHDRAWN
Last Update Posted:
2021-05-26
First Post:
2010-09-01
Brief Title:
Axium Coil in Completing Endovascular Aneurysm Surgery Study
Sponsor:
Medtronic Neurovascular Clinical Affairs
Organization:
Medtronic Neurovascular Clinical Affairs
Study Overview
Official Title:
Axium Coil in Completing Endovascular Aneurysm Surgery Study A Single-center Prospective Observational Registry
Status:
WITHDRAWN
Status Verified Date:
2021-05
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:
ACCESS
Brief Summary:
The current observational evaluation is designed to evaluate the performance of the Axium MicroFx Detachable Coil System for the treatment of intracranial aneurysms in the real life practice
Detailed Description:
Up to 25 patients from from US centers are anticipated to be enrolled for this evaluation Published literature on coils with electrolytic thermal or hydraulic detachment will serve as the basis for control comparisons to the Axium MicroFx Detachable Coil System for patients undergoing embolization of intracranial aneurysm Comparison will be based on criteria evaluating the safety of the procedure the reliability of detachment the occlusion stability and the packing density impact
Study Oversight
Has Oversight DMC:
None
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?:
None