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

December 30, 2025 updated by: Ton-Bridge Medical Tech. Co., Ltd

Efficacy and Safety of the Self-expanding Intracranial Stent (Tonbridge) for Endovascular Treatment of Intracranial Aneurysms: A Prospective, Multi-center, Randomized, Open, Parallel Positive Controlled, Non-inferiority Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
204

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • China
      • Chongqing, China
        • The First Affiliated Hospital of Chongqing Medical University
      • Shanghai, China
        • Changhai Hospital of Shanghai
    • Anhui
      • Wuhu, Anhui, China
        • The First Affiliated Hospital of Wannan Medical College
    • Guangdong
      • Guangzhou, Guangdong, China
        • Guangdong Provincial People's Hospital
      • Guangzhou, Guangdong, China
        • ZhuJiang Hospital of Southern Medical University
      • Zhuhai, Guangdong, China
        • Zhuhai People's Hospital
    • Hubei
      • Wuhan, Hubei, China
        • Tongji Hospital Tongji Medical College Of Hust
    • Hunan
      • Changsha, Hunan, China
        • Xiangya Hospital of Central South University
    • Jiangsu
      • Nanjing, Jiangsu, China
        • General Hospital of Eastern Theater Command
    • Liaoning
      • Shenyang, Liaoning, China
        • General Hospital of Northern Theater Command
    • Shandong
      • Jinan, Shandong, China
        • Qilu Hospital of Shandong University
    • Shanxi
      • Taiyuan, Shanxi, China
        • First Hospital of Shanxi Medical University
    • Sichuan
      • Chengdu, Sichuan, China
        • Sichuan Academy of Medical Sciences·Sichuan Provincial People's Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China
        • The First Affiliated Hospital Zhejiang University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: experimental group
Self-expanding Intracranial Stent (Tonbridge)
Device: Self-expanding Intracranial Stent (Tonbridge)
Stent assisted coiling with Self-expanding Intracranial Stent (Tonbridge).
Active Comparator: control group
LVIS and LVIS Jr. (MicroVention)
Device: LVIS and LVIS Jr. (MicroVention)
Stent assisted coiling with LVIS and LVIS Jr. (MicroVention).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Successful occlusion rate of aneurysms at 6 months
Time Frame: 6 months±30 days post-procedure
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Device success rate
Time Frame: intra-procedure
Device success is that the stent is delivered to the target vessel successfully and covers the aneurysm neck effectively without stent migration or misplacement, etc. Device success is diagnosed by intraoperative cerebrovascular DSA.
intra-procedure
Immediate successful occlusion rate of aneurysms
Time Frame: intra-procedure
Successful occlusion is defined as complete occlusion or neck remnant (Raymond-Roy class I or Ⅱ), which is diagnosed by intraoperative cerebrovascular DSA.
intra-procedure
Recurrence rate of aneurysms at 6 months
Time Frame: 6 months±30 days post-procedure
Recurrence is defined as increased contrast agent filling into the aneurysm sac at post-operative review compared to immediate post-procedure.
6 months±30 days post-procedure
Retreatment rate
Time Frame: 180±30 days, 360±30 days post-procedure
Retreatment is defined as during the study period any additional treatment of the target aneurysm after the original procedure.
180±30 days, 360±30 days post-procedure
Operation satisfaction rate
Time Frame: intra-procedure
The 5-point Likert scale is used to evaluate the operation satisfaction from three aspects: push performance, retracting performance and release performance. "Operation satisfaction rate" is defined as the proportion of investigational devices or comparators with Likert score≥12 points.
intra-procedure
Incidence of parent artery stenosis (>50%) in target area
Time Frame: 180±30 days, 360±30 days post-procedure
Parent artery stenosis in target area is defined as stenosis degree >50%, which is diagnosed by postoperative cerebrovascular DSA at 6 months, CTA or MRA at 12 months.
180±30 days, 360±30 days post-procedure
Incidence of parent artery occlusion in target area
Time Frame: 180±30 days, 360±30 days post-procedure
Parent artery occlusion in target area is diagnosed by postoperative cerebrovascular DSA at 6 months, CTA or MRA at 12 months.
180±30 days, 360±30 days post-procedure
Incidence of stroke
Time Frame: 30±7 days, 360±30 days post-procedure
Stroke includes hemorrhagic stroke and symptomatic ischemic stroke.
30±7 days, 360±30 days post-procedure
All-cause mortality
Time Frame: 30±7 days, 360±30 days post-procedure
"All-cause mortality" is the proportion of subjects who die due to any cause.
30±7 days, 360±30 days post-procedure
Incidence of adverse events
Time Frame: 180±30 days, 360±30 days post-procedure
"Incidence of adverse events" is the proportion of subjects with adverse events using the investigational device or the comparator.
180±30 days, 360±30 days post-procedure
Incidence of serious adverse events
Time Frame: 180±30 days, 360±30 days post-procedure
"Incidence of serious adverse events" is the proportion of subjects with serious adverse events using the investigational device or the comparator.
180±30 days, 360±30 days post-procedure
Incidence of device deficiency
Time Frame: intra-procedure, 180±30 days post-procedure
Device deficiency is the unreasonable risk that may endanger human health and life safety in the normal use of medical devices during clinical trials, such as labeling errors, quality problems and malfunctions.
intra-procedure, 180±30 days post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ton-Bridge Medical Tech. Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Chuanzhi Duan, Southern Medical University, China
  • Principal Investigator: Jianmin Liu, Changhai Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 14, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 10, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 13, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 6, 2023

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 30, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ZHTQ202202

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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