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New stents aim to seal dangerous brain aneurysms

NCT ID NCT04566263

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tested two stent systems (Neuroform EZ and Neuroform Atlas) used with coils to treat wide-neck brain aneurysms. Wide-neck aneurysms are hard to seal because coils can fall out. The stents act like a scaffold to keep coils in place. 30 adults with unruptured, wide-neck aneurysms took part. The main goal was to see if the aneurysm could be at least 90% sealed.

What this could mean

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

Active substance
Neuroform EZ and Neuroform Atlas stent systems (medical devices)
What this could lead to
If successful, this could provide a safer, more effective way to seal wide-neck brain aneurysms and prevent them from bleeding.
What could go wrong
This is a small, completed study with only 30 participants. Results may not apply to everyone, and there are risks from the procedure and required anti-platelet medication.

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

30 people

The number who actually took part.

Started

Feb 2017

Finished

Jan 2021

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 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, * Inability to tolerate anti-platelet medication

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Conditions

The condition(s) this trial relates to.

brain aneurysm intracranial berry aneurysm

As listed by the trial registrant

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

Intracranial aneurysms

Contacts and locations

Locations

  • Methodist Dallas Medical Center

    Dallas, Texas, 75203, United States

More trials for these conditions

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