Ignite Creation Date:
2024-05-06 @ 6:45 PM
Last Modification Date:
2024-10-26 @ 2:54 PM
Study NCT ID:
NCT05774782
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2023-03-06
Brief Title:
Parent Artery Reconstruction for Cerebral Aneurysms Using a Novel Flow Diverter With Surface Modification
Sponsor:
Sinomed Neurovita Technology Inc
Organization:
Sinomed Neurovita Technology Inc
Study Overview
Official Title:
A Prospective Multi-center Single Arm Clinical Study to Evaluate the Safety and Effectiveness of the Flow Diverter Stent System in the Treatment of Cerebral Aneurysms
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-04
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:
The primary objective of this trial is to evaluate the safety and efficacy of the cerebral flow diverter in the endovascular treatment of wide-necked cerebral aneurysms
Detailed Description:
The investigation is a prospective multi-center single arm clinical study The trial is anticipated to last from March 2023 to January 2025 with 143 subjects recruited in around 10 China centers The population for this study is subjects with wide-necked intracranial aneurysms who are suitable candidates for flow diverter implantation Patients fulfilling all of the inclusion criteria and none of the exclusion criteria will be enrolled after offering informed consent form The study consists of six visits including preoperative screening operation date 7days or at discharge 30 days 180 days and 1 year The primary endpoint is success aneurysm occlusion at 1 year post procedure
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