Stent shows promise for brain aneurysm repair
NCT ID NCT05774782
First seen Jun 26, 2026 · Last updated Jul 14, 2026 · Updated 3 times
Summary
This study tested a special stent designed to divert blood flow away from brain aneurysms, helping them heal. It involved 143 people with unruptured, wide-necked aneurysms. The main goal was to see if the stent could completely seal the aneurysm within a year without causing major strokes or artery narrowing.
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 stent
- What this could lead to
- If successful, this stent could offer a less invasive way to treat brain aneurysms, potentially reducing the need for open surgery.
- What could go wrong
- This is a single-arm study with no comparison group, so results may not be definitive. Risks include stroke or incomplete aneurysm sealing.
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
-
143 people
The number who actually took part.
- Started
-
Mar 2023
- Finished
-
Aug 2024
- 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 75 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 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 years to 75 years, male or non-pregnant female. 2. Unruptured wide-necked cerebral aneurysms confirmed by preoperative imaging (Wide-necked is defined as width ≥ 4 mm or a dome-to-neck ratio \< 2). 3. Parent vessel with a diameter range of 1.75-6.0 mm. 4. Those who voluntarily participate in the study and sign informed consent form. Exclusion Criteria: 1. Subject with target aneurysms are blood blister-like aneurysms, pseudoaneurysms, arteriovenous malformation, moyamoya disease-related aneurysm, or multiple aneurysms that cannot be treated with a single stent. 2. Severe arteriosclerosis or tortuosity of intracranial artery, and the device is difficult to reach the target vessel. 3. Subject with target aneurysm previously treated with craniotomy or other endovascular interventional therapy. 4. Known sensitivity to antiplatelet medications, anticoagulant medications, radiographic contrast agents, anesthetic, nickel, platinum-tungsten alloy, platinum-iridium alloy, and poly-N-\[Tris(hydroxymethyl)methyl\] acrylamide (poly-NTMA). 5. Severe respiratory system, liver and kidney diseases (such as creatinine ≥ 3.0 mg/dL (except dialysis)) or blood coagulation disorders before operation. 6. Platelet count is less than 100×109/L, international normalized ratio (INR) is more than 1.5. 7. Hospitalized surgical treatment within the previous 30 days or planned within the next 180 days after operation. 8. Severe neurological deficit that renders the patient incapable of living independently (modified Rankin score ≥3). 9. The survival expectation is less than 1 year. 10. All subjects who are participating in other drug/medical device clinical trials and have not completed the programme requirements 11. Inapplicable for this study at the investigators' viewpoints.
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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
-
Xuanwu Hospital Capital Medical University
Beijing, China
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Other studies related to the condition(s) this trial covers.
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