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

NCT ID: NCT04918420

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 142 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-07-07
• Study Completion Date: 2023-03-09

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Flow Diverter (Tonbridge)

Treatment with Flow Diverter (Tonbridge)

Group Type: EXPERIMENTAL

Flow Diverter (Tonbridge)

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age 18 to 80 years, any gender;
• A single unruptured intracranial aneurysm locates in the intracranial segment of internal carotid artery (ICA) or vertebral artery (VA), which diagnosed by DSA;
• The maximal diameter of the target aneurysm < 10 mm diagnosed by DSA;
• The target aneurysm with a neck ≥ 4 mm or a dome to neck ratio < 2 diagnosed by DSA;
• The target aneurysm with a parent vessel diameter of 2.0-6.5 mm;
• Subject or guardian is able to understand the purpose of study, shows sufficient compliance with the study protocol and provides a signed informed consent form.

Exclusion Criteria

• Diagnosed as with cerebrovascular malformations;
• Intracranial hemorrhage within 30 days pre-procedure;
• Modified Rankin Scale (mRS) score ≥ 3 in pre-procedure;
• Platelet (PLT) < 60×10^9/L or known platelet dysfunction or International Normalized Ratio (INR) > 1.5;
• Heart, lung, liver and renal failure or other severe diseases (such as intracranial tumor, systemic infection, disseminated intravascular coagulation, myocardial infarction within 12 months before enrollment, history of severe psychosis, severe stenosis or occlusion of cerebral feeding artery);
• Subject who is not appropriate for flow diverter delivery and deployment judged by investigators (severe stenosis of parent artery, severe tortuosity of parent artery, stent failing to reach the lesion, stent in the target lesion of parent artery, etc.);
• Major surgery within 30 days before enrollment, or intending to receive surgery within 180 days after enrollment;
• Allergic history of anesthetics and contrast agents, or contraindication for dual antiplatelet or/and anticoagulant therapy;
• Allergic history of metals such as nickel-titanium alloy;
• Life expectancy < 12 months;
• Pregnant or breastfeeding women;
• Subject has participated in other drug or medical device clinical trials within 1 month before signing informed consent;
• Other conditions judged by the investigators as unsuitable for enrollment.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ton-Bridge Medical Tech. Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jianmin Liu

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Locations

The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China

Henan Provincial People's Hospital

Zhengzhou, Henan, China

Nanjing Drum Tower Hospital

Nanjing, Jiangsu, China

Zhejiang Hospital

Hangzhou, Zhejiang, China

Xinqiao Hospital, Army Medical University

Chongqing, , China

Changhai Hospital of Shanghai

Shanghai, , China

Huashan Hospital Fudan University

Shanghai, , China

Countries

China

Other Identifiers

ZHTQ2021002

Identifier Type: -

Identifier Source: org_study_id