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New stent shows promise for tricky brain aneurysms

NCT ID NCT05254067

Disease control Sponsor: Methodist Health System 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested a special stent (Enterprise 2) used with coils to treat wide-neck brain aneurysms. Ten adults with this condition received the procedure. Researchers checked if the stent stayed in place, shortened, or narrowed over time. The goal was to see if this device can safely and effectively seal the aneurysm.

What this could mean

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

Active substance
Codman Enterprise 2 Vascular Reconstruction Device (a stent used with coil embolization)
What this could lead to
If successful, this stent could offer a safer, more reliable way to treat wide-neck brain aneurysms, reducing the risk of coils escaping or the stent moving.
What could go wrong
This was a very small study (10 people) with no comparison group. The device may still cause complications like stent narrowing or migration, and results may not apply to all patients.

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.

Participants

10 people

The number who actually took part.

Started

Feb 2017

Finished

Jan 2026

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.

Who is studied

Participants will be initially assessed and if included, will undergo procedure that includes use of the device.

Ages

18 years and older

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: * Adult patients (18 years old or older) with intracranial aneurysms with a wide neck (defined as \> or = to 4mm, or with a dome to neck ratio of 2:1 or greater). Exclusion Criteria: * Small-necked aneurysms, inappropriate for stenting. * Inability to tolerate anti-platelet medication.

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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.

Aneurysm

Contacts and locations

Locations

  • Moody Brain and Spine Institute at Methodist Dallas Medical Center

    Dallas, Texas, 75203, United States

More trials for these conditions

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