Ignite Creation Date:
2024-07-17 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06466564
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-20
First Post:
2024-03-04
Brief Title:
BioabsorbableNufairy Coil Application Trial in China
Sponsor:
MicroPort NeuroTech Co Ltd
Organization:
MicroPort NeuroTech Co Ltd
Study Overview
Official Title:
A Prospective Multi-center Open-label Non-inferiority Randomized Controlled Trial of BioabsorbableNufairy Coil Embolization System for the Treatment of Intracranial Aneurysms
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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:
NuCATCH
Brief Summary:
The scope of this trial is the collection and analysis of effectiveness and safety endpoints related to the use of the BioabsorbableNufairy Coil Embolization System in the treatment of intracranial aneurysms
Detailed Description:
Approximately 258 subjects with intracranial aneurysms would be enrolled for coiling embolization according to the inclusion and exclusion criteria specified in this trial protocol Subjects were evaluated by mRS preoperatively at the time of device implantation at the time of discharge from the hospital at 1 month 7 days postoperatively at 6 months 30 days postoperatively and at 12 months 90 days postoperatively subjects would underwent DSA imaging at surgery and at 12months 90 days postoperatively and MRA imaging at 18 months 90 days postoperatively Unplanned follow-up of the subjects would performed when necessary and data would be recorded to evaluate the safety and efficacy of Nufairy Coil Embolization System for coiling embolization for the treatment of intracranial aneurysms
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?:
None