International Retrospective Study of Pipeline Embolization Device (IntrePED)

November 20, 2013 updated by: Medtronic Neurovascular Clinical Affairs

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

793

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, C1426EOB
        • Clínica La Sagrada Familia
  • Canada
    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7N0W8
        • Royal University Hospital
  • France
      • Montpellier, France, 34295
        • Hopital Gui de Chauliac
  • Hungary
      • Budapest, Hungary, H-1145
        • National Institute of Neurosciences
  • Italy
      • Milan, Italy, 20162
        • A.O. Ospedale Niguarda Ca' Granda
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85013
        • Barrow Neurosurgical Associates
    • Florida
      • Jacksonville, Florida, United States, 32082
        • Mayo Clinic
    • Illinois
      • Chicago, Illinois, United States, 60612
        • Rush University Hospital
    • Kentucky
      • Louisville, Kentucky, United States, 40241
        • Norton Neuroscience Institute
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Abbott Northwestern Hospital
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • New York
      • Buffalo, New York, United States, 14203
        • University of Buffalo Neurosurgery, Buffalo General Hospital
      • Stony Brook, New York, United States, 11794
        • SUNY Stony Brook
    • Oregon
      • Portland, Oregon, United States, 97239
        • Oregon Health & Science University
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19107
        • Thomas Jefferson University
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina
    • Tennessee
      • Knoxville, Tennessee, United States, 37916
        • Fort Sanders Regional Medical Center, Neurovascular Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with brain aneurysms who were treated with the Pipeline Embolization Device

Description

Inclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Relative incidence of neurologic clinical events that occurred after treatment with PED
Time Frame: From Approval of PED in country of use until IRB approval at facility allowing for approximately 8-12 months of data for each subject. Outcomes are expected to be reported on 6 mo, 12mo, 2 yr, & 5yr data.
Incidence of neurologic events from the time of Approval of the Pipeline Embolization Device in the country of use until IRB approval at facility.
From Approval of PED in country of use until IRB approval at facility allowing for approximately 8-12 months of data for each subject. Outcomes are expected to be reported on 6 mo, 12mo, 2 yr, & 5yr data.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Neurovascular Clinical Affairs

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

March 8, 2012

First Submitted That Met QC Criteria

March 16, 2012

First Posted (Estimate)

March 20, 2012

Study Record Updates

Last Update Posted (Estimate)

November 25, 2013

Last Update Submitted That Met QC Criteria

November 20, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PED001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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