Aneurysm Study of Pipeline in an Observational Registry

Stopped early

Conditions studied: Brain Aneurysm

In brief

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 facts

Study ID

NCT01557036

Run by

Medtronic Neurovascular Clinical Affairs

People needed

200

Starts

2012-06-21

Expected to finish

2014-06-05

Last updated by the study team

2026-06-29

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• (All sites, All countries)
• At least 1 Pipeline placed for treatment of an ICA
• Patient or patient's Legally Authorized Representative (LAR) has signed an IRB- or EC-approved informed consent form, if required
• 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)
• Active bacterial infection
• A patient in whom dual antiplatelet therapy (aspirin and clopidogrel) is contraindicated
• A patient who has not received dual antiplatelet agents prior to the procedure
• Pre-existing stent is in place in the parent artery at the target aneurysm location
• Angiography demonstrates inappropriate anatomy, e.g., severe pre-or post-aneurysm narrowing
• 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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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