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New brain aneurysm stent shows promise in clinical trial

NCT ID NCT05755516

Disease control Sponsor: Ton-Bridge Medical Tech. Co., Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a new stent called Tonbridge for treating brain aneurysms (weak spots in blood vessels). It involved 204 people aged 18 to 80 who needed a stent to help place coils inside the aneurysm. The goal was to see if the new stent works as well as an existing device at blocking blood flow to the aneurysm after 6 months.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

204 people

The number who actually took part.

Started

Feb 2023

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

brain aneurysm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intracranial aneurysm

Contacts and locations

Locations

  • Changhai Hospital of Shanghai

    Shanghai, China

  • First Hospital of Shanxi Medical University

    Taiyuan, Shanxi, China

  • General Hospital of Eastern Theater Command

    Nanjing, Jiangsu, China

  • General Hospital of Northern Theater Command

    Shenyang, Liaoning, China

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, China

  • Qilu Hospital of Shandong University

    Jinan, Shandong, 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

  • The First Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui, China

  • Tongji Hospital Tongji Medical College of HUST

    Wuhan, Hubei, China

  • Xiangya Hospital of Central South University

    Changsha, Hunan, China

  • Zhuhai People's Hospital

    Zhuhai, Guangdong, China

  • Zhujiang Hospital of Southern Medical University

    Guangzhou, Guangdong, China

More trials for these conditions

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