New brain aneurysm device gets first human test
NCT ID NCT07259018
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early study will test a new device called the LuSeed Aneurysm Embolization System in 10 people with unruptured brain aneurysms. The device is designed to block blood flow to the aneurysm, reducing the risk of rupture. The main goals are to see if the device is safe and can be placed correctly during a minimally invasive procedure.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- LuSeed Aneurysm Embolization System (a device implanted via catheter to block blood flow to the aneurysm)
- What this could lead to
- If successful, this could provide a new, less invasive treatment option for people with unruptured brain aneurysms.
- What could go wrong
- This is a very early, small study (10 people) focused only on safety and whether the device can be placed correctly. It is not designed to prove the device works long-term, and there are risks like stroke or death.
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
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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
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About 10 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Dec 2025
An estimate. Start dates often move.
- Expected to finish
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May 2028
An estimate. End dates often move.
- 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.
- Ages
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18 to 80 years
- 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: 1. Patients indicated for treatment of unruptured intracranial aneurysms (IA) according to AHA / ASA Guidelines. 2. Age 18-80 years at screening 3. Patients who are suitable for non-emergency endovascular embolization of saccular IAs 4. The IA must have had the following characteristics: * IA located in bifurcation in the anterior or posterior circulation * IA dimensions appropriate for treatment with LuSeed- Vascular Embolization Device per implant size selection guidelines as outlined in the Instructions for Use (IFU) and as follows: * IA Width: 2.5-5.5\[mm\] * IA Neck: 2.0-5.0\[mm\] * IA Height: min 4.0 \[mm\]- device short configuration, min 5.0 \[mm\]-device long configuration • The AI must meet the definition of a "wide-neck" aneurysm. 5. Patient is willing and able to participate in the study for the duration of the study follow-up and can comply with study requirements 6. Patient able to give their informed consent can be included in this study. Exclusion Criteria: 1. Ruptured intracranial aneurysm 2. Patient anatomy or physiology considered unsuitable for endovascular treatment as determined by imaging Core Lab 3. Contraindication for arterial access 4. Intracranial aneurysm neck diameter less than 2mm or greater than 5 mm 5. Intracranial aneurysm sac diameter less than 2.5mm or greater than 5.5mm 6. Intracranial aneurysm minimum height less than 4.0 mm 7. Target Intracranial aneurysm contains other devices/implants (e.g., coils) 8. Stenosis of the target IA's parent vessel \>50% 9. Known allergy to platinum, nickel, or titanium 10. Known allergy to contrast agents 11. Absolute contraindication to anticoagulation or antiplatelet therapy 12. Anticoagulation medications such as warfarin that cannot be discontinued 13. Pregnant, breastfeeding or planning pregnancy within next 12 months 14. Acute or chronic renal failure (stage III or IV by VARC-3 criteria) 15. Cerebral embolism, stroke, or TIA in past 6 months 16. Myocardial infarction in the past 6 months 17. Any other medical issue within the brain that would preclude device implantation (such as brain surgery, radiation in the target area of intervention from an external beam source, acute traumatic craniocerebral injury, etc.) 18. Patient had any circulatory, neurovascular, cardiovascular, or neurologic conditions that resulted in unstable neurological symptoms at screening. 19. Patient had physical, neurologic or psychiatric conditions which precluded his/her ability to comply with all aspects of the screening, evaluation, treatment, and the postprocedure follow-up schedule. 20. Other medical conditions that cause an inability to comply with study requirements and/or that could increase the risk of neurovascular procedures (e.g., extreme frailty, liver failure, cancer, heart failure, chronic obstructive pulmonary disease, immunosuppression, neural disease, and hematologic disorders etc.) 21. Patient had a life expectancy of less than 12 months. 22. Current participation in another study with investigational devices or drugs that would confound the effect of the study outcomes.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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.
Contacts and locations
Locations
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St. Michael's Hospital - Unity Health Toronto
Toronto, Ontario, M5C 1R6, Canada
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Other studies related to the condition(s) this trial covers.
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