Ignite Creation Date:
2024-05-06 @ 3:53 PM
Last Modification Date:
2024-10-26 @ 1:59 PM
Study NCT ID:
NCT04799964
Status:
COMPLETED
Last Update Posted:
2023-09-25
First Post:
2021-02-20
Brief Title:
Efficacy and Safety of the Flow Diverter Tonbridge for Endovascular Treatment of Intracranial Aneurysms
Sponsor:
Zhuhai Tonbridge Medical Tech Co Ltd
Organization:
Zhuhai Tonbridge Medical Tech Co Ltd
Study Overview
Official Title:
Efficacy and Safety of the Flow Diverter Tonbridge for Endovascular Treatment of Intracranial Aneurysms a Prospective Multi-center Randomized Open Positive-controlled Non-inferiority Trial
Status:
COMPLETED
Status Verified Date:
2024-09
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 purpose of this study is to assess the efficacy and safety of the Flow Diverter Tonbridge for endovascular treatment of intracranial aneurysms
Detailed Description:
This is a prospective multi-center randomized open positive-controlled non-inferiority trial This clinical trial is conducted at more than 5 centers in China Eligible patients are randomized into experimental group using Flow Diverter Tonbridge or control group using Tubridge MicroPort in a 11 ratio The primary objective of this study is to verify the complete occlusion rate of aneurysms at 12 months of Flow Diverter Tonbridge is non-inferior to Tubridge for treatment of intracranial aneurysms and evaluate the effectiveness and safety of the Flow Diverter Tonbridge
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