New mesh stent aims to seal brain aneurysms without surgery
NCT ID NCT07228312
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
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2026
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
8 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Chenzhou No.1 People's Hospital
RECRUITINGChenzhou, 432000, China
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Guangdong Provincial People's Hospital
RECRUITINGGuangzhou, 519041, China
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Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
RECRUITINGNanjing, 210008, China
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Nanyang Central Hospital
RECRUITINGNanyang, 473000, China
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Shanxi Provincial People's Hospital
RECRUITINGTaiyuan, 30012, China
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The First Affiliated Hospital of Nanjing Medical University
RECRUITINGNanjing, 210029, China
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The First Affiliated Hospital of Wannan Medical College
RECRUITINGWuhu, 241001, China
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The First Affiliated Hospital of Zhengzhou University
RECRUITINGZhengzhou, 450052, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- New stents aim to seal off dangerous brain aneurysms without open surgery
- Can small brain aneurysms be safely watched instead of treated?
- Can a pill tame the inflammation behind brain aneurysms?
- AI could sharpen the art of brain aneurysm repair
- Pompe disease may raise risk of brain aneurysms, new study investigates