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New stent device aims to better seal brain aneurysms

NCT ID NCT07372612

Disease control Sponsor: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School Source: ClinicalTrials.gov ↗

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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study compares a newer flow-diverting stent to standard stent-assisted coiling for treating unruptured brain aneurysms in the middle cerebral artery. About 140 adults aged 18-70 will be randomly assigned to one of the two procedures. The main goal is to see which method more completely closes the aneurysm and reduces the chance of it coming back, while also checking safety and neurological function.

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 (Lattice stent) with optional coiling
What this could lead to
If successful, this could establish a more effective treatment for certain brain aneurysms, reducing the chance of recurrence and improving patient outcomes.
What could go wrong
This is a single-center Phase 4 trial with 140 participants, so results may not apply broadly. Both procedures carry risks like bleeding or stroke, and the flow diverter may not prove superior.

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

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 140 people

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

Expected to start

Jan 2026

An estimate. Start dates often move.

Expected to finish

Oct 2028

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

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. Unruptured wide-necked middle cerebral artery bifurcation aneurysms definitively diagnosed by CTA or DSA; 2. Aneurysms requiring stent-assisted embolization with the necessity of preserving branch arteries; 3. Indication for either flow diversion device or conventional stent-assisted coiling; 4. Age between 18 and 70 years, inclusive; 5. The subject or their legally authorized representative has signed the written informed consent form. Exclusion Criteria: 1. Concomitant significant organ dysfunction (e.g., severe cardiac, hepatic, or renal insufficiency), chronic inflammatory disease, or malignancy; 2. Pregnant or lactating women; 3. Presence of significant neurological deficit (mRS score \> 2); 4. Presence of contraindications to flow diversion device or stent-assisted coiling (e.g., severe allergy to metallic material, contraindication to antiplatelet medication); 5. Other conditions deemed unsuitable for enrollment by the investigator.

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Conditions

The condition(s) this trial relates to.

Aneurysm brain aneurysm

As listed by the trial registrant

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

Aneurysms Coiling therapy Flow diverter Middle cerebral artery aneurysm

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. 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 ↗

  2. 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.

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