Brain aneurysm blood flow software tested for predicting stent success
NCT ID NCT03663257
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
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132 people
The number who actually took part.
- Started
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Oct 2018
- Finished
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Nov 2023
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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
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Baptist Health
Jacksonville, Florida, 32207, United States
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ENERI
Buenos Aires, C1428 CABA, Argentina
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Toronto Western Hospital
Toronto, Ontario, M5T 2S8, Canada
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UMass Medical Center
Worcester, Massachusetts, 01655, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a pill tame the inflammation behind brain aneurysms?
- AI could sharpen the art of brain aneurysm repair
- Pompe disease may raise risk of brain aneurysms, new study investigates