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Brain aneurysm device study halted early

NCT ID NCT04391803

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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 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

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

25 people

The number who actually took part.

Started

May 2022

Finished

Oct 2025

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.

Ages

22 to 80 years

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: 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

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822, United States

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • Semmes Murphey Clinic

    Memphis, Tennessee, 38120, United States

  • Stony Brook University Hospital

    Stony Brook, New York, 11794, United States

  • University of Kentucky Albert B Chandler Hospital

    Lexington, Kentucky, 40506, United States

  • Wellstar Kennestone Hospital

    Marietta, Georgia, 30060, United States

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510, United States

More trials for these conditions

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