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Efficacy and Safety of the Flow Diverter (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms

Intracranial Aneurysm Clinical Trial

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

Clinical Trial Summary

The purpose of this study is to assess the efficacy and safety of the Flow Diverter (Tonbridge) for endovascular treatment of intracranial aneurysms.

Clinical Trial 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 1:1 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04799964
Study type Interventional
Source Zhuhai Tonbridge Medical Tech. Co., Ltd.
Contact Danqing Shen
Phone 15858207851
Email dq.shen@ton-bridge.com
Status Recruiting
Phase N/A
Start date August 12, 2021
Completion date December 2023
View Details
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