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New stents aim to seal off dangerous brain aneurysms without open surgery

NCT ID NCT07821957

Disease control Sponsor: Beijing Tiantan Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Researchers in China are studying whether newer flow diverter stents can safely and effectively treat wide-neck brain aneurysms. About 280 patients will receive one of these stents, which is threaded through blood vessels to the brain and left in place to redirect blood flow away from the aneurysm. The goal is to see how often the aneurysm seals off completely after one year, with follow-up for up to four years to track safety and durability.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a new-generation flow diverter stent placed inside the artery to reroute blood away from the aneurysm
What this could lead to
If the stents work well, doctors could have stronger evidence for using them as a first-choice option for wide-neck brain aneurysms, possibly with fewer invasive surgeries.
What could go wrong
The study follows patients for up to four years, but it is not randomized, so results may reflect which patients were chosen rather than the stent itself. Stents can fail to seal the aneurysm, shift, or cause bleeding or clots, and patients must take blood thinners for months.

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

About 280 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Dec 2030

An estimate. End dates often move.

Lead sponsor

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

22 to 80 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: * Signed informed consent form and agreement to comply with protocol requirements. Age 22 to 80 years. Diagnosed with intracranial wide-neck aneurysm and planned for treatment with a flow diverter stent. Parent artery distal/proximal diameter compatible with available sizes and models of flow diverter stents, and treatment to be performed in accordance with the China NMPA-approved indications and instructions for use. Exclusion Criteria: * Need for treatment of another aneurysm in the affected territory of the target aneurysm using a different therapeutic modality during the study period. Prior intracranial implant (e.g., coils) in the target intracranial aneurysm territory within 6 months before enrollment. Prior surgery, including endovascular treatment, within 30 days before enrollment. Modified Rankin Scale (mRS) score ≥ 3. Any known contraindication to flow diverter stent treatment or antiplatelet therapy, including contraindications to dual antiplatelet therapy (DAPT). Pre-existing stent/flow diverter placed in the parent artery of the target aneurysm location. Investigator judges that the patient's health or the validity of study results (e.g., high risk of neurological events, conditions that may increase the chance of stroke) could be compromised by study participation. Women who are pregnant, breastfeeding, or planning to become pregnant during the study period. Known allergy to platinum or cobalt-chromium alloys (including major elements: platinum, cobalt, chromium, nickel, or molybdenum).

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Conditions

The condition(s) this trial relates to.

brain aneurysm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intracranial aneurysm

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

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Contacts and locations

Locations

  • Beijing Tiantan Hospital, Capital Medical University

    RECRUITING

    Beijing, Beijing Municipality, 100070, China

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