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

NCT05755516 | Completed

• 1 other identifier: ZHTQ202202
• Study Type: interventional
• Target: 204
• Locations: 1 country
• Sites: 14

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.

Conditions

Intracranial Aneurysm

Outcome Measures

Primary Outcomes (1)

• Successful occlusion rate of aneurysms at 6 months

  Successful occlusion is defined as complete occlusion or neck remnant (Raymond-Roy class I or Ⅱ), which is diagnosed by cerebrovascular DSA at 6 months post-procedure.

  6 months±30 days post-procedure

Secondary Outcomes (12)

• Device success rate

  intra-procedure

• Immediate successful occlusion rate of aneurysms

  intra-procedure

• Recurrence rate of aneurysms at 6 months

  6 months±30 days post-procedure

• Retreatment rate

  180±30 days, 360±30 days post-procedure

• Operation satisfaction rate

  intra-procedure

Study Arms (2)

experimental group

EXPERIMENTAL

Self-expanding Intracranial Stent (Tonbridge)

Device: Self-expanding Intracranial Stent (Tonbridge)

control group

ACTIVE COMPARATOR

LVIS and LVIS Jr. (MicroVention)

Device: LVIS and LVIS Jr. (MicroVention)

Interventions

LVIS and LVIS Jr. (MicroVention) DEVICE

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

control group

Self-expanding Intracranial Stent (Tonbridge) DEVICE

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

experimental group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ton-Bridge Medical Tech. Co., Ltd: lead

Study Sites (14)

The First Affiliated Hospital of Wannan Medical College

Wuhu, Anhui, China

Location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Location

Zhujiang Hospital of Southern Medical University

Guangzhou, Guangdong, China

Location

Zhuhai People's Hospital

Zhuhai, Guangdong, China

Location

Tongji Hospital Tongji Medical College of HUST

Wuhan, Hubei, China

Location

Xiangya Hospital of Central South University

Changsha, Hunan, China

Location

General Hospital of Eastern Theater Command

Nanjing, Jiangsu, China

Location

General Hospital of Northern Theater Command

Shenyang, Liaoning, China

Location

Qilu Hospital of Shandong University

Jinan, Shandong, China

Location

First Hospital of Shanxi Medical University

Taiyuan, Shanxi, China

Location

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

Chengdu, Sichuan, China

Location

The First Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location

The First Affiliated Hospital of Chongqing Medical University

Chongqing, China

Location

Changhai Hospital of Shanghai

Shanghai, China

Location

MeSH Terms

Conditions

Intracranial Aneurysm

Condition Hierarchy (Ancestors)

Intracranial Arterial Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Aneurysm; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Jianmin Liu

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

• Chuanzhi Duan

  Southern Medical University, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 6, 2023
• Study Start: February 14, 2023
• Primary Completion: March 10, 2024
• Study Completion: December 13, 2024
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

CN (14)