International Retrospective Study of Pipeline Embolization Device

NCT ID: NCT01558102

Last Updated: 2024-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

793 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2013-07-31

Brief Summary

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The primary objective of this retrospective study is to determine the incidence of important safety outcomes in patients who have undergone Pipeline Embolization Device placement for intracranial aneurysms (IAs). This study does not effect patient care, simply it is designed to observe and capture information from numerous hospitals.

Data collection will be initiated starting March 2012 and continue until approximately April 2017.

Detailed Description

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Conditions

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Brain Aneurysms

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* A patient who was treated with the Pipeline Embolization Device for treatment of a brain aneurysm
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic Neurovascular Clinical Affairs

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Barrow Neurosurgical Associates

Phoenix, Arizona, United States

Site Status

Mayo Clinic

Jacksonville, Florida, United States

Site Status

Rush University Hospital

Chicago, Illinois, United States

Site Status

Norton Neuroscience Institute

Louisville, Kentucky, United States

Site Status

Abbott Northwestern Hospital

Minneapolis, Minnesota, United States

Site Status

Mayo Clinic

Rochester, Minnesota, United States

Site Status

University of Buffalo Neurosurgery, Buffalo General Hospital

Buffalo, New York, United States

Site Status

SUNY Stony Brook

Stony Brook, New York, United States

Site Status

Oregon Health & Science University

Portland, Oregon, United States

Site Status

Thomas Jefferson University

Philadelphia, Pennsylvania, United States

Site Status

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status

Fort Sanders Regional Medical Center, Neurovascular Research

Knoxville, Tennessee, United States

Site Status

Clínica La Sagrada Familia

Buenos Aires, , Argentina

Site Status

Royal University Hospital

Saskatoon, Saskatchewan, Canada

Site Status

Hôpital Gui de Chauliac

Montpellier, , France

Site Status

National Institute of Neurosciences

Budapest, , Hungary

Site Status

A.O. Ospedale Niguarda Ca' Granda

Milan, , Italy

Site Status

Countries

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United States Argentina Canada France Hungary Italy

References

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Park MS, Kilburg C, Taussky P, Albuquerque FC, Kallmes DF, Levy EI, Jabbour P, Szikora I, Boccardi E, Hanel RA, Bonafe A, McDougall CG. Pipeline Embolization Device with or without Adjunctive Coil Embolization: Analysis of Complications from the IntrePED Registry. AJNR Am J Neuroradiol. 2016 Jun;37(6):1127-31. doi: 10.3174/ajnr.A4678. Epub 2016 Jan 14.

Reference Type DERIVED
PMID: 26767709 (View on PubMed)

Other Identifiers

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PED001

Identifier Type: -

Identifier Source: org_study_id

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