Ignite Creation Date:
2024-05-05 @ 11:23 PM
Last Modification Date:
2024-10-26 @ 10:33 AM
Study NCT ID:
NCT01323439
Status:
COMPLETED
Last Update Posted:
2017-08-30
First Post:
2011-03-23
Brief Title:
Axium MicroFX for Endovascular Repair of IntraCranial Aneurysm-A Multicenter Study
Sponsor:
Medtronic Neurovascular Clinical Affairs
Organization:
Medtronic Neurovascular Clinical Affairs
Study Overview
Official Title:
Axium MicroFX for Endovascular Repair of IntraCranial Aneurysm-A Multicenter Study
Status:
COMPLETED
Status Verified Date:
2017-08
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:
AMERICA
Brief Summary:
This is a multicenter prospective single-arm trial evaluating the safety and efficacy of the Axium MicroFX coil system in 100 aneurysms
Detailed Description:
This is a multicenter prospective single-arm trial evaluating the safety and efficacy of the Axium MicroFX coil system in 99 patients at 13 study centers The primary endpoint of the trial was the anatomic occlusion of the aneurysm in the immediate post-procedure angiogram basedon the Raymond classification Secondary endpoints included safety during the procedure safety after the procedure detachment system performance stability of the embolization and packing efficacy
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None