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Real-World data on brain aneurysm device could improve patient safety

NCT ID NCT01557036

Knowledge-focused 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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 29, 2026 · Last updated Jun 30, 2026 · Updated 1 time

Summary

This study observes people who have already been treated with the Pipeline Embolization Device for brain aneurysms. Researchers track neurological complications like stroke or bleeding to better understand the device's safety in everyday use. The goal is to expand knowledge on how well the device works outside of controlled clinical trials.

What this could mean

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

Active substance
Pipeline Embolization Device
What this could lead to
If successful, this registry could provide real-world evidence on the safety and effectiveness of the Pipeline device for brain aneurysms.
What could go wrong
This is an observational study, not a controlled trial, so it cannot prove cause and effect. Results may be influenced by patient selection or other factors.

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

200 people

The number who actually took part.

Started

Jun 2012

Finished

Jun 2014

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 with an intracranial aneurysm meeting the labeled indication for the relevant geography.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

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: (All sites, All countries) 1. At least 1 Pipeline placed for treatment of an ICA 2. Patient or patient's Legally Authorized Representative (LAR) has signed an IRB- or EC-approved informed consent form, if required 3. Patient is willing and able to comply with follow-up visits United States: Additional Inclusion Criteria for subjects enrolled in the United States: 4US) Subjects who are age 22 or higher 5US) IA of at least 10 mm in maximum dimension along the internal carotid artery between the petrous and superior hypophyseal segments Canada: Additional Inclusion Criteria for subjects enrolled in Canada: 4C) In Canada, the Pipeline™ Embolization Device is intended for use with or without embolic coils for the treatment of complex intracranial aneurysms that are not amenable to treatment with surgical clipping. 5C) Canadian licensing/approval is limited to devices that are between 3.25 mm and 5.00 mm in diameter. France: Additional Inclusion Criteria for subjects enrolled in France: 4F) Unruptured IA, saccular or fusiform with an aneurysm sac diameter \> 15mm and not treatable with other current therapies ( EVT with coils with or without assisting system (intracranial stent) or balloon remodeling, or surgery) due to its specific morphology. 5F) IA previously treated with unruptured recanalization of the aneurismal sac \> 7 mm, not treatable with conservative treatment. Exclusion Criteria: (based on contraindications PED IFU) 1. Active bacterial infection 2. A patient in whom dual antiplatelet therapy (aspirin and clopidogrel) is contraindicated 3. A patient who has not received dual antiplatelet agents prior to the procedure 4. Pre-existing stent is in place in the parent artery at the target aneurysm location 5. Angiography demonstrates inappropriate anatomy, e.g., severe pre-or post-aneurysm narrowing 6. Acutely ruptured aneurysm, defined as rupture of the target aneurysm Each site should refer to their country specific Instructions for Use/Approval(France) to determine final eligibility into the ASPIRe Registry.

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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.

Brain aneurysm

Contacts and locations

Locations

  • Abbott Northwestern Hospital/Consulting Radiologists

    Minneapolis, Minnesota, 55407, United States

  • Alfried Krupp Krankenhaus

    Essen, 45131, Germany

  • Barrow Neurosurgical Associates

    Phoenix, Arizona, 85013, United States

  • Besançon University Hospital

    Besançon, 25030, France

  • Clínica La Sagrada Familia

    Buenos Aires, C1426EOB, Argentina

  • Fondazione Istituto Neurologico "Besta"

    Milan, 20133, Italy

  • Hôpital Gui de Chauliac

    Montpellier, 34295, France

  • Hôpital Maison Blanche - CHU

    Reims, 51100, France

  • Klinikum Stuttgart

    Stuttgart, 70174, Germany

  • Mayo Clinic

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic

    Rochester, Minnesota, 55905, United States

  • Medical College Of Wisconsin/Froedtert Hospital

    Milwaukee, Wisconsin, 53226, United States

  • Medical University of South Carolina

    Charleston, South Carolina, 29425, United States

  • Neurointerventional Associates, P.A.

    St. Petersburg, Florida, 33701, United States

  • Neurosurgical Associates at Central Baptist

    Lexington, Kentucky, 40503, United States

  • Niguarda CA Granda Hospital of Milan

    Milan, 20162, Italy

  • Norton Neuroscience Institute

    Louisville, Kentucky, 40241, United States

  • Oregon Health and Science University

    Portland, Oregon, 97239, United States

  • Ospedale San Giovanni Bosco ASL Napoli 1 Centro

    Naples, 80144, Italy

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033, United States

  • Radiology Imaging Associates / Colorado Neurological Institute

    Englewood, Colorado, 80113, United States

  • Ronald Reagan UCLA Medical Center

    Los Angeles, California, 90095, United States

  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8, Canada

  • Rush University Medical Center

    Chicago, Illinois, 60612, United States

  • St. Luke's Episcopal Hospital

    Houston, Texas, 77030, United States

  • St. Paul Radiology

    Saint Paul, Minnesota, 55102, United States

  • The Methodist Hospital

    Houston, Texas, 77030, United States

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio, 43210, United States

  • The State University of New York, Stony Brook

    Stony Brook, New York, 11794, United States

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107, United States

  • Universitair Ziekenhuis Gent

    Ghent, 9000, Belgium

  • University Hospitals of Geneva (HUG)

    Geneva, 1211, Switzerland

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of Buffalo Neurosurgery, Buffalo General Hospital

    Buffalo, New York, 14203, United States

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792, United States

  • Washington University

    St Louis, Missouri, 63110, United States

More trials for these conditions

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