Brain aneurysm device study halted early
NCT ID NCT04391803
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looked at a device called the Pipeline Flex Embolization Device with Shield Technology to treat ruptured brain aneurysms that are hard to fix with surgery or coils. The goal was to see if it could safely block the aneurysm and prevent rebleeding. The study was stopped early, and only 25 people were enrolled.
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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25 people
The number who actually took part.
- Started
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May 2022
- Finished
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Oct 2025
- 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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22 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. Subject has a previously untreated, wide neck, side-wall, intradural aneurysm that is deemed unfavorable for both surgical clipping and endovascular coiling, as confirmed on DSA. 2. Subject has a ruptured intracranial aneurysm with vessel diameter suitable for treatment with the study device. 3. Subject is ≥ 22 and ≤ 80 years of age. 4. Subject has an acutely ruptured aneurysm with Hunt and Hess Scale 1, 2 or 3. 5. Subject or subject's Legally Authorized Representative (LAR) has provided written informed consent. Exclusion Criteria: 1. Subject's vessel characteristics preclude safe endovascular access to the aneurysm to treat with the Pipeline™ Shield Device. 2. Subject has aneurysm vessel characteristics that would preclude the device from fully conforming to the parent vessel to reduce any risk of embolic complications, retreatment, or device movement. 3. Subject has true bifurcation or aneurysms with vessels that cannot be separated from the fundus with placement of the study device. 4. Subject with intraparenchymal hemorrhage. 5. Subject is unable to undergo nasogastric/orogastric tube placement prior to device placement. 6. Subject has a pre-morbid mRS \>2. 7. Subject requires treatment of another aneurysm (with another treatment modality) within the affected territory of the target aneurysm. 8. Subject has a target ruptured aneurysm that is thought to be mycotic, including those caused by left atrial myxoma, or subject has an active systemic bacterial infection. 9. Subject with a requirement for continuous anti-coagulation. 10. Subject has a malignant brain tumor or vascular malformation (e.g. arteriovenous malformation). 11. Subject's target ruptured aneurysm has not been determined by the treating physician to be the source of SAH. 12. Subject with known allergy to platinum or cobalt chromium alloy (including the major elements platinum, cobalt, chromium, nickel or molybdenum). 13. Subject has a known hypersensitivity to ticagrelor or aspirin. 14. Subject is unable to undergo DSA or DSA is determined unsuitable by the treating physician. 15. Subject has a serious or life-threatening comorbidity that could confound study results. 16. Subject is at high risk of noncompliance per treating physician due to reasons including but not limited to a history of substance abuse. 17. Subject is unable to complete scheduled follow-up assessments due to comorbidities, geographical limitations, or a life expectancy of less than 24 months. 18. Subject is pregnant, or breastfeeding at the time of admission or plans to become pregnant during their participation in the study. 19. Subject is participating in another clinical study at the time of enrollment. 20. Presumed septic embolus, or suspicion of microbial superinfection. 21. Subject with a known COVID-19 viral infection, confirmed by testing. 22. Subject in whom a pre-existing stent is in place in the parent artery at target aneurysm location.
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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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Geisinger Medical Center
Danville, Pennsylvania, 17822, United States
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Rush University Medical Center
Chicago, Illinois, 60612, United States
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Semmes Murphey Clinic
Memphis, Tennessee, 38120, United States
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Stony Brook University Hospital
Stony Brook, New York, 11794, United States
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University of Kentucky Albert B Chandler Hospital
Lexington, Kentucky, 40506, United States
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Wellstar Kennestone Hospital
Marietta, Georgia, 30060, United States
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Yale New Haven Hospital
New Haven, Connecticut, 06510, United States
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Other studies related to the condition(s) this trial covers.
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