Which brain aneurysm treatment is safer? a Head-to-Head test
NCT ID NCT07754188
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This study compares two procedures used to treat unruptured wide-neck brain aneurysms: flow diverter stents and stent-assisted coiling. Researchers will follow 274 adults from three centers in China who receive one of these treatments as part of routine care. The main question is whether one approach leads to fewer strokes or deaths within 30 days after the procedure. The findings could help doctors choose the safer option for this type of aneurysm.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Flow diverter device or stent-assisted coiling procedure
- What this could lead to
- If one approach proves safer, it could guide doctors toward the better treatment for wide-neck brain aneurysms, reducing stroke risk.
- What could go wrong
- This is an observational study, not a randomized trial, so results may be influenced by patient differences. Complications like stroke or death are possible with either 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.
- Participants
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About 274 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2026
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients aged 18 to 75 years with unruptured, saccular, wide-neck intracranial bifurcation aneurysms diagnosed by CTA, MRA, or DSA who meet the clinical indications for endovascular treatment and are treated at participating centers. Eligible patients must provide written informed consent and will receive either flow diverter treatment or stent-assisted coiling according to the study protocol.
- Ages
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18 to 75 years
- 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: * Voluntarily provides written informed consent. * Aged 18 to 75 years. * Diagnosed by CTA, MRA, or DSA as having an unruptured, bifurcation, saccular, wide-neck intracranial aneurysm. * Able to understand the purpose of the study. Exclusion Criteria: * Patients with two or more multiple aneurysms, all of which require treatment within 1 year. * Patients with other cerebrovascular diseases such as arteriovenous malformation or moyamoya disease. * Patients with ruptured aneurysms or narrow-neck aneurysms. * Patients who experienced stroke, including cerebral hemorrhage or cerebral infarction, within the past 1 month. * Patients with poor clinical condition, defined as modified Rankin Scale score ≥3. * Patients who have already planned to undergo surgical or interventional treatment within 3 months. * Patients considered by the investigator to be unsuitable for endovascular treatment, such as those with no suitable vascular access, excessively tortuous vessels, or difficulty in stent delivery. * Patients unsuitable for anesthesia or endovascular treatment, including those with major heart, lung, liver, spleen, or kidney disease, brain tumor, severe active infection, disseminated intravascular coagulation, or a history of severe psychiatric disorder. * Patients unable to receive antiplatelet or anticoagulant therapy. * Patients with a previous or possible severe reaction to contrast agents that would prevent completion of pre-treatment medication or treatment. * Patients with a known history of allergy to cobalt-chromium or nickel-titanium alloy materials. * Patients who participated in another drug or medical device clinical trial before enrollment and have not reached the time point of the primary endpoint. * Pregnant or lactating women. * Patients with life expectancy less than 12 months. * Patients judged by the investigator to have poor compliance and inability to complete the study as required
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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
3 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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Guangdong Province People's Hospital
RECRUITINGGuangzhou, China
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Nanfang Hospital, Southern Medical University
RECRUITINGGuangzhou, Guangdong, China
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Zhujiang Hospital, Southern Medical University
RECRUITINGGuangzhou, China
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Other studies related to the condition(s) this trial covers.
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