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Brain aneurysm blood flow software tested for predicting stent success

NCT ID NCT03663257

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 software tool called AneurysmFlow that measures blood flow in brain aneurysms. The goal was to see if it can predict whether an aneurysm will fully close 12 months after a stent is placed. 132 adults with unruptured brain aneurysms participated. The tool is already approved for use, and this study aims to confirm its predictive value.

What this could mean

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

Active substance
AneurysmFlow software (a device that analyzes blood flow images from angiograms)
What this could lead to
If successful, this tool could help doctors predict which brain aneurysms will close after stent placement, potentially guiding treatment decisions.
What could go wrong
This is an observational study, not a treatment trial. The tool is already approved, but its real-world benefit for patients is still being evaluated. Results may not apply to all aneurysm types.

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

132 people

The number who actually took part.

Started

Oct 2018

Finished

Nov 2023

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.

Who is studied

Patients with age 18 or older, of both genders and all races. Patients are considered to be enrolled in the study after they have signed the informed consent form.

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: * Subject with unruptured, ≥5mm saccular aneurysm(s) located in the anterior intracranial circulation and suitable for an endovascular treatment with a Flow Diverter Stent * Subject is 18 years of age or older, or of legal age to give informed consent per state or national law. * Subject is available for clinical follow-ups. Exclusion Criteria: * Non-saccular brain aneurysm(s) (i.e. dissecting, fusiform, atherosclerotic, mycotic, bifurcational). Prior aneurysm treatment with either endovascular (stenting, coiling) or surgical (clipping) techniques. * Endovascular treatment assisted with coils or intracranial stents * Significant or severe allergy to intra-arterial contrast medium uncontrolled by pre-procedure medications. * Severe kidney disease (Glomerular Filtration Rate \< 60). * Subjects not willing (or able) to attend post FDS insertion standard-of-care follow up clinic visits requiring DSA, head MRI or CTA imaging. * Subject participates in a potentially confounding drug or device trial during the course of the study. * Subject meets an exclusion criteria according to national law (e.g. age, pregnant woman, breast feeding woman).

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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

  • Baptist Health

    Jacksonville, Florida, 32207, United States

  • ENERI

    Buenos Aires, C1428 CABA, Argentina

  • Toronto Western Hospital

    Toronto, Ontario, M5T 2S8, Canada

  • UMass Medical Center

    Worcester, Massachusetts, 01655, United States

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