New device for brain aneurysms under Real-World watch
NCT ID NCT06604884
First seen Jun 27, 2026 · Last updated Aug 13, 2026 · Updated 2 times
Summary
This study follows 118 people getting a special device called Pipeline Vantage to treat brain aneurysms. The device is placed inside the blood vessel to block the aneurysm and prevent rupture. Researchers will check how well it works and if there are any problems one year after the procedure.
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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About 118 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2025
- Expected to finish
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Sep 2033
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.
Who is studied
Patients requiring treatment for intracranial aneurysms with the market approved Pipeline™ Vantage Embolization Device with Shield Technology™ device are eligible for the registry
- Ages
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22 years and older
- Sex
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Anyone
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. Patient or legally authorized representative (LAR) has provided written informed consent using the Ethics Board and Medtronic approved Informed Consent Form and agrees to comply with the protocol requirements. HIPAA/data protection authorization has been provided and signed by the patient (or patient's LAR) as applicable per local law. 2. Patient has an intracranial aneurysm intended to be treated with the Pipeline™ Vantage Embolization Device with Shield Technology™. 3. Patient is an adult per local law at time of consent. Exclusion Criteria: 1. Patient with any contraindications for the device or procedure per the Pipeline™ Vantage Device local geography IFU. 2. Patient who may be unable to complete the study follow-up. 3. The Investigator determined that the health of the patient may be compromised by the patient's enrollment. 4. Female patient who is known to be pregnant or is breastfeeding or wishes to become pregnant during participation in the study. 5. Patient is currently enrolled in, or plans to enroll in, any concurrent drug/device study that may confound the study results.
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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
8 sites. 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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Ascension St. Vincent Hospital Indianapolis Goodman Campbell Brain and Spine
RECRUITINGCarmel, Indiana, 46032-3318, United States
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Baptist Medical Center Jacksonville
RECRUITINGJacksonville, Florida, 32207, United States
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McLaren Healthcare
RECRUITINGFlint, Michigan, 48532, United States
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Prisma Health
RECRUITINGGreenville, South Carolina, 29605, United States
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Semmes Murphey Clinic/Semmes Murphy Foundation
RECRUITINGMemphis, Tennessee, 38120, United States
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University of Iowa Hospitals and Clinics
RECRUITINGIowa City, Iowa, 52242, United States
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Washington University in Saint Louis
RECRUITINGSt Louis, Missouri, 63130, United States
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Wellstar Research Institute
RECRUITINGMarietta, Georgia, 30060, United States
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Other studies related to the condition(s) this trial covers.
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- Can small brain aneurysms be safely watched instead of treated?
- 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