Efficacy and Safety of the Self-expanding Intracranial Stent (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms

NCT ID: NCT05755516

Last Updated: 2026-01-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 204 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-14
• Study Completion Date: 2024-12-13

Brief Summary

The purpose of this study is to assess the efficacy and safety of Self-expanding Intracranial Stent (Tonbridge), by comparing the data obtained from Self-expanding Intracranial Stent (Zhuhai Tonbridge Medical Tech. Co., Ltd.) and LVIS/LVIS Jr. (MicroVention Europe SARL) for endovascular treatment of intracranial aneurysms.

Detailed Description

This is a prospective, multi-center, randomized, open, parallel positive controlled, non-inferiority trial. This clinical trial is conducted at more than 2 centers in China, and patients who intend to be treated with stent-assisted coiling for intracranial aneurysms are enrolled. Eligible patients are randomized into experimental group using Self-expanding Intracranial Stent (Tonbridge) or control group using LVIS and LVIS Jr. (MicroVention) in a 1:1 ratio. The purpose of this study is to evaluate the effectiveness and safety of the Self-expanding Intracranial Stent (Tonbridge).

Conditions

Intracranial Aneurysm

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

experimental group

Self-expanding Intracranial Stent (Tonbridge)

Group Type: EXPERIMENTAL

Self-expanding Intracranial Stent (Tonbridge)

Intervention Type: DEVICE

Stent assisted coiling with Self-expanding Intracranial Stent (Tonbridge).

control group

LVIS and LVIS Jr. (MicroVention)

Group Type: ACTIVE_COMPARATOR

LVIS and LVIS Jr. (MicroVention)

Intervention Type: DEVICE

Stent assisted coiling with LVIS and LVIS Jr. (MicroVention).

Interventions

Self-expanding Intracranial Stent (Tonbridge)

Stent assisted coiling with Self-expanding Intracranial Stent (Tonbridge).

Intervention Type: DEVICE

LVIS and LVIS Jr. (MicroVention)

Stent assisted coiling with LVIS and LVIS Jr. (MicroVention).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• Age 18 to 80 years, any gender;
• Diagnosed as intracranial aneurysm and the subject is assessed as suitable for stent-assisted coiling;
• 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

• Aneurysm rupture within 30 days before enrollment;
• Diagnosed as blood blister-like aneurysm, pseudoaneurysm, infected aneurysm, or aneurysm related to arteriovenous malformations;
• Conditions that are not appropriate for stent 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.);
• Modified Rankin Scale (mRS) score ≥3;
• Heart, lung, liver and renal failure or other severe diseases (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, etc.);
• Major surgery within 30 days before enrollment；
• Known coagulation dysfunction or contraindication to anticoagulant and antiplatelet therapy;
• Known allergy to nickel-titanium alloy metal materials;
• 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

Chuanzhi Duan

Role: PRINCIPAL_INVESTIGATOR

Southern Medical University, China

Locations

The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Zhuhai People's Hospital

Zhuhai, Guangdong, China

Tongji Hospital Tongji Medical College of HUST

Wuhan, Hubei, China

Xiangya Hospital of Central South University

Changsha, Hunan, China

General Hospital of Eastern Theater Command

Nanjing, Jiangsu, China

General Hospital of Northern Theater Command

Shenyang, Liaoning, China

Qilu Hospital of Shandong University

Jinan, Shandong, China

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Sichuan Academy of Medical Sciences·Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

The First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The First Affiliated Hospital of Chongqing Medical University

Chongqing, , China

Changhai Hospital of Shanghai

Shanghai, , China

Countries

China

Other Identifiers

ZHTQ202202

Identifier Type: -

Identifier Source: org_study_id