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TERMINATED

Aneurysm Study of Pipeline in an Observational Registry

NCT01557036•Medtronic Neurovascular Clinical Affairs

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.

Eligibility

Age

All ages

Sex

ALL

Healthy Volunteers

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
•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
•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.
•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

•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

Key Dates

Start Date

May 1, 2012

Primary Completion Date

May 1, 2014

Last Updated

January 21, 2015

Enrollment

200

ACTUAL participants

Conditions

Brain Aneurysm

Interventions

Pipeline Embolization Device

DEVICE

Post Market Registry Study of Intracranial Aneurysms Treated With Sugita Clipping Devices

NCT06798740

Brain Aneurysm

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 21, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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