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New mesh stent aims to seal brain aneurysms without surgery

NCT ID NCT07228312

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 28, 2026 · Updated 4 times

Summary

This study is testing a new device called the Choydar flow-directed mesh stent for people with unruptured brain aneurysms—weak spots in blood vessels that could burst. The stent is placed inside the artery to block blood flow into the aneurysm, helping it heal. Researchers will follow 200 participants for 12 months to see how well the stent works and if it causes any serious side effects like stroke or bleeding.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Choydar flow-directed mesh stent
What this could lead to
If successful, this stent could offer a safer, less invasive way to seal brain aneurysms and prevent them from bursting.
What could go wrong
This is an observational study, not a randomized trial, so results may be less definitive. Risks include stroke, bleeding, or stent narrowing.

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.

Participants

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Feb 2028

An estimate. End dates often move.

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.

Who is studied

Adult participants with unruptured wide-neck (neck width \>= 4 mm or dome-to-neck ratio \<2) saccular or fusiform aneurysms in the internal carotid artery (from the petrous segment to the distal end) and the vertebral artery arising from a parent vessel with a diameter \>= 2.0 mm and \<= 6.0 mm.

Ages

18 years and older

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: Participants meeting all the following inclusion criteria will be included: Preoperative inclusion criteria: * Presence of unruptured aneurysms in the internal carotid artery (from the petrous segment to the distal end) or vertebral artery identified by digital subtraction angiography (DSA), computed tomography angiography (CTA), or magnetic resonance angiography (MRA) prior to surgery, wide-neck (neck width greater than or equal to \[\>=\] 4 millimeters \[mm\] or dome-to-neck ratio less than \[\<\] 2) saccular or fusiform aneurysms, and the parent artery diameter must be \>= 2.0 mm and less than or equal to \[\<=\] 6.0 mm * Participants and/or their authorized representatives understand the purpose of the study, and are willing to voluntarily participate in the study and sign the informed consent form (ICF) * Prior to enrollment, a clinical decision has already been made to use the choydar flow-directed mesh stent * Participants who are willing and able to return for all follow-up visits as required by the study protocol Intraoperative inclusion criteria: \- Presence of unruptured aneurysms in the internal carotid artery (from the petrous segment to the distal end) or vertebral artery identified by DSA during the procedure, wide-neck (neck width \>= 4 mm or dome-to-neck ratio \<2) saccular or fusiform aneurysms, and the parent artery diameter must be \>= 2.0 mm and \<= 6.0 mm Exclusion criteria: Participants meeting any of the following exclusion criteria will be excluded: * Participants with anatomy are unsuitable for flow diverter passage or placement or lesions unsuitable for flow diverter delivery and deployment (for example, the lesion vessel is excessively tortuous or tiny, the flow diverter cannot reach the lesion site, stenosis exists in the target vessel of recurrent aneurysm, or the flow diverter is not completely deployed) * Participants who are allergic to contrast media * Participants who are allergic to nickel-titanium alloy or platinum-tungsten alloy * Participants who are contraindicated for antiplatelet and/or anticoagulant therapy * Participants with active bacterial infections * Participants who are confirmed positive pregnancy (for example, via test or oral communication) according to the site-specific standard of care * Participants who are currently participating in an investigational (drug, device, etc.) clinical study that may confound the study endpoints (excluding observational, natural history, and/or epidemiological studies that do not require interventions)

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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.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    8 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Chenzhou No.1 People's Hospital

    RECRUITING

    Chenzhou, 432000, China

  • Guangdong Provincial People's Hospital

    RECRUITING

    Guangzhou, 519041, China

  • Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School

    RECRUITING

    Nanjing, 210008, China

  • Nanyang Central Hospital

    RECRUITING

    Nanyang, 473000, China

  • Shanxi Provincial People's Hospital

    RECRUITING

    Taiyuan, 30012, China

  • The First Affiliated Hospital of Nanjing Medical University

    RECRUITING

    Nanjing, 210029, China

  • The First Affiliated Hospital of Wannan Medical College

    RECRUITING

    Wuhu, 241001, China

  • The First Affiliated Hospital of Zhengzhou University

    RECRUITING

    Zhengzhou, 450052, China

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