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NCT01557036

Aneurysm Study of Pipeline in an Observational Registry

Sponsor: Medtronic Neurovascular Clinical Affairs

View on ClinicalTrials.gov

Summary

The primary objective of this study is to further expand the body of clinical knowledge in patients undergoing Pipeline Embolization Device (Pipeline or PED) placement for intracranial aneurysms (IAs or ICAs) according to Pipeline's labeled indication.

Key Details

Gender

All

Age Range

Any - Any

Study Type

OBSERVATIONAL

Enrollment

200

Start Date

2012-06-21

Completion Date

2014-06-05

Last Updated

2026-06-29

Healthy Volunteers

Conditions

Brain Aneurysm

Interventions

DEVICE

Pipeline Embolization Device

Aneurysms treated independent of study entry with the Pipeline Embolization Device. This is an observational, non-interventional study.

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.

Locations (36)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Barrow Neurosurgical Associates

Phoenix, Arizona, United States

Ronald Reagan UCLA Medical Center

Los Angeles, California, United States

Radiology Imaging Associates / Colorado Neurological Institute

Englewood, Colorado, United States

Mayo Clinic

Jacksonville, Florida, United States

Neurointerventional Associates, P.A.

St. Petersburg, Florida, United States

Rush University Medical Center

Chicago, Illinois, United States

Neurosurgical Associates at Central Baptist

Lexington, Kentucky, United States

Norton Neuroscience Institute

Louisville, Kentucky, United States

Abbott Northwestern Hospital/Consulting Radiologists

Minneapolis, Minnesota, United States

Mayo Clinic

Rochester, Minnesota, United States

St. Paul Radiology

Saint Paul, Minnesota, United States

Washington University

St Louis, Missouri, United States

University of Buffalo Neurosurgery, Buffalo General Hospital

Buffalo, New York, United States

The State University of New York, Stony Brook

Stony Brook, New York, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

Oregon Health and Science University

Portland, Oregon, United States

Penn State Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, United States

Medical University of South Carolina

Charleston, South Carolina, United States

St. Luke's Episcopal Hospital

Houston, Texas, United States

The Methodist Hospital

Houston, Texas, United States

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, United States

Medical College Of Wisconsin/Froedtert Hospital

Milwaukee, Wisconsin, United States

Clínica La Sagrada Familia

Buenos Aires, Argentina

Universitair Ziekenhuis Gent

Ghent, Belgium

Royal University Hospital

Saskatoon, Saskatchewan, Canada

Besançon University Hospital

Besançon, France

Hôpital Gui de Chauliac

Montpellier, France

Hôpital Maison Blanche - CHU

Reims, France

Alfried Krupp Krankenhaus

Essen, Germany

Klinikum Stuttgart

Stuttgart, Germany

Niguarda CA Granda Hospital of Milan

Milan, Italy

Fondazione Istituto Neurologico "Besta"

Milan, Italy

Ospedale San Giovanni Bosco ASL Napoli 1 Centro

Naples, Italy

University Hospitals of Geneva (HUG)

Geneva, Switzerland