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Brain aneurysm device under Real-World watch: will it hold up?

NCT ID NCT05071963

Disease control Sponsor: Medtronic Neurovascular Clinical Affairs Source: ClinicalTrials.gov ↗

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 This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 11, 2026 · Updated 3 times

Summary

This study follows 246 people who received the Pipeline Shield device to treat brain aneurysms. The device is a small mesh tube that blocks blood flow to the aneurysm, reducing rupture risk. Researchers are checking how well the aneurysm seals, whether the artery narrows, and if repeat treatment is needed within one year.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Pipeline™ Flex Embolization Device with Shield Technology™ (a device used to block blood flow to brain aneurysms)
What this could lead to
If successful, this study could confirm that the Pipeline Shield device is a safe and effective option for treating brain aneurysms in everyday medical practice.
What could go wrong
This is an observational study, not a controlled trial, so results may not prove the device is better than other treatments. Risks include incomplete aneurysm sealing or artery narrowing.

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

246 people

The number who actually took part.

Started

Dec 2021

Expected to finish

Apr 2028

An estimate. End dates often move.

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.

Who is studied

Patients requiring treatment for intracranial aneurysms with the market approved Pipeline™ Flex Embolization Device with Shield Technology™ device are eligible for the registry

Ages

22 years and older

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. Patient or legally authorized representative (LAR) provides authorization and/or consent per institution and geographical requirements. 2. Patient is intended to receive or be treated with an eligible Medtronic product. 3. Patient is consented within the enrollment window of the therapy received, as applicable. 4. Patient or patient's legally authorized representative (LAR) has provided written informed consent using the IRB and Medtronic approved Informed Consent Form and agrees to comply with the study requirements. HIPAA/data protection authorization has been provided and signed by the patient (or patient's LAR). 5. Patient has already been selected for endovascular treatment of the target aneurysm with the Pipeline™ Shield Device as the appropriate treatment per the Pipeline™ Shield Device Instructions For Use (IFU). Exclusion Criteria: 1. Patient who is, or is expected to be, inaccessible for follow-up. 2. Participation is excluded by local law. 3. Patient is currently enrolled or plans to enroll in a concurrent drug/device study that may confound the PSR results (i.e. no required intervention that could affect interpretation of all-around product safety and/or effectiveness). 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 contraindicated for the device or procedure per the Pipeline™ Shield Device IFU. 6. The Investigator determined that the health of the patient may be compromised by the patient's enrollment. 7. Patient is enrolled or planning to participate in a potentially confounding drug or device trial during the course of this study. Co-enrollment in concurrent trials is only allowed when documented pre-approval was obtained from Medtronic.

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Conditions

The condition(s) this trial relates to.

brain aneurysm

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Intracranial aneurysm

Contacts and locations

Locations

  • Baptist Medical Center Jacksonville

    Jacksonville, Florida, 32207, United States

  • Baylor Scott & White Research Institute

    Dallas, Texas, 75201, United States

  • Emory University Hospital

    Atlanta, Georgia, 30322, United States

  • Endeavor Health - Evanston Hospital

    Evanston, Illinois, 60201, United States

  • Geisinger Medical Center

    Danville, Pennsylvania, 17822-9800, United States

  • Hospital of the University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • Montefiore Medical Center

    New York, New York, 10467-2401, United States

  • NYU Langone Medical Center

    New York, New York, 10016-6402, United States

  • Norton Healthcare

    Louisville, Kentucky, 40202, United States

  • Oklahoma (OU) University Medical Center

    Oklahoma City, Oklahoma, 73104, United States

  • Prisma Health

    Greenville, South Carolina, 29605, United States

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Utah Hospital

    Salt Lake City, Utah, 84132-0001, United States

  • Washington University in Saint Louis

    St Louis, Missouri, 63130, United States

  • Yale New Haven Hospital

    New Haven, Connecticut, 06510, United States

More trials for these conditions

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