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New brain aneurysm device shows promise in 142-Patient trial

NCT ID NCT04918420

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 medical device called the Tonbridge flow diverter to treat brain aneurysms (weak spots in blood vessels). The device is placed inside the artery to redirect blood flow away from the aneurysm, helping it heal. The trial included 142 people aged 18 to 80 with unruptured aneurysms in specific brain arteries. The main goal was to see if the aneurysm was completely blocked at 12 months after the procedure.

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

142 people

The number who actually took part.

Started

Jul 2021

Finished

Mar 2023

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; * 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.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Changhai Hospital of Shanghai

    Shanghai, China

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, China

  • Huashan Hospital Fudan University

    Shanghai, China

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, China

  • The First Affiliated Hospital of Wannan Medical College

    Wuhu, Anhui, China

  • Xinqiao Hospital, Army Medical University

    Chongqing, China

  • Zhejiang Hospital

    Hangzhou, Zhejiang, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.