Brain aneurysm showdown: which procedure is safer?
NCT ID NCT07707076
First seen Jul 16, 2026 · Last updated Jul 17, 2026 · Updated 1 time
Summary
This trial compares two endovascular procedures for treating unruptured wide-neck brain aneurysms: a flow diverter device (Pipeline) versus traditional stent-assisted coiling. About 266 adults aged 18–75 with these aneurysms will be randomly assigned to one treatment and followed for up to 5 years. The goal is to see which approach has fewer complications like stroke or death, and which leads to better long-term aneurysm closure.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- a flow diverter device (Pipeline) or a stent-assisted coiling procedure
- What this could lead to
- If one approach proves safer and more effective, it could become the preferred treatment for these hard-to-treat brain aneurysms, reducing stroke risk and improving long-term outcomes.
- What could go wrong
- This is a randomized trial, but results may not apply to all aneurysm types or patients. Both procedures carry risks like stroke or vessel damage, and long-term benefits are still being studied.
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
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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
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About 266 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2026
- Expected to finish
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Jun 2030
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.
- 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: 1. Age 18-75 years; 2. Diagnosis of unruptured intracranial, bifurcation, saccular, wide-neck aneurysm by DSA/CTA/MRA; 3. Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form. Exclusion Criteria: 1. Patients with two or more multiple aneurysms that all require treatment within 1 year; 2. Concomitant cerebrovascular diseases such as arteriovenous malformation, moyamoya disease; 3. Ruptured aneurysms and narrow-neck aneurysms; 4. Patients who have had a stroke (cerebral hemorrhage, cerebral infarction) within the past 1 month; 5. Extremely poor clinical condition, modified Rankin Score ≥3; 6. Patients already scheduled for surgery/interventional procedure within 3 months; 7. Patients deemed unsuitable for interventional treatment by the investigator (e.g., no suitable vascular access, excessively tortuous vessels, difficulty delivering stent); 8. Patients unsuitable for anesthesia or endovascular surgery, such as major diseases of heart, lung, liver, spleen, kidney, brain tumors, severe active infections, disseminated intravascular coagulation, severe mental illness; 9. Patients unable to receive antiplatelet or anticoagulant therapy; 10. Patients who have had or may have severe reactions to contrast media precluding pre-treatment medication; 11. Patients with a definite history of allergy to cobalt-chromium, nickel-titanium alloy materials; 12. Participation in other drug or medical device clinical trials before enrollment without reaching the primary endpoint timeframe; 13. Pregnant or breastfeeding women; 14. Patient's life expectancy less than 12 months; 15. Investigator judges that the patient has poor compliance and cannot 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
1 site. 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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Nanfang Hospital, Southern Medical University
RECRUITINGGuangzhou, Guangdong, 510515, China