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Stent shows promise for brain aneurysm repair

NCT ID NCT05774782

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 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

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

More trials for these conditions

Other studies related to the condition(s) this trial covers.