Ignite Creation Date:
2024-05-06 @ 8:14 PM
Last Modification Date:
2024-10-26 @ 3:23 PM
Study NCT ID:
NCT06303063
Status:
RECRUITING
Last Update Posted:
2024-04-01
First Post:
2024-03-04
Brief Title:
Compare the Safety and Effectiveness of Two Different Kinds of Stent System in Intracranial Aneurysms
Sponsor:
Sinomed Neurovita Technology Inc
Organization:
Sinomed Neurovita Technology Inc
Study Overview
Official Title:
A Prospective Multicenter Randomized Controlled Trial to Evaluate the Safety and Effectiveness of the SINOMED IAS for the Treatment of Intracranial Aneurysms
Status:
RECRUITING
Status Verified Date:
2024-03
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 SINOMED IAS in patients with intracranial aneurysms
Detailed Description:
This study is a prospective multicenter 11 randomized clinical trial to evaluate the safety and efficacy of stent system in the treatment of intracranial aneurysms A total of 204 patients are planned to be included The primary endpoint is the incidence of success aneurysm occlusion at 6-month post procedure All patients will have clinical follow-up during intraoperative 30 days 6 months 1 year
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