NCT04918420

A Single-arm Trial of the Flow Diverter (Tonbridge) For Endovascular Treatment of Intracranial Aneurysms

Efficacy and Safety of the Flow Diverter (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms: A Prospective, Multi-center, Single-arm Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Ton-Bridge Medical Tech. Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the effectiveness and safety of the Flow Diverter (Tonbridge) by collecting data from subjects who receive endovascular treatment of intracranial aneurysms.

Detailed description

This is a prospective, multi-center, single-arm clinical trial carried out in 7 research centers over China. In this study, enrolled patients are treated with the Flow Diverter (Tonbridge) for intracranial aneurysms. The objective of this study is to evaluate the effectiveness and safety of the Flow Diverter (Tonbridge) for treatment of intracranial aneurysms.

Conditions

• Intracranial Aneurysm

Interventions

Type	Name	Description
DEVICE	Flow Diverter (Tonbridge)	The device is a self-expanding vascular stent system, which consists of a stent and a delivery system. The stent is made of platinum core nickel-titanium alloy material. The delivery system is composed of a delivery guide wire and an introducer sheath. The stent and the delivery guide wire are pre-installed in the introducer sheath.

Timeline

• Start date: 2021-07-07
• Primary completion: 2023-03-09
• Completion: 2023-03-09
• First posted: 2021-06-08
• Last updated: 2026-01-02

Locations

7 sites across 1 country: China