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International Retrospective Study of Pipeline Embolization Device (IntrePED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01558102
Recruitment Status : Completed
First Posted : March 20, 2012
Last Update Posted : November 25, 2013
Sponsor:
Information provided by (Responsible Party):
Medtronic Neurovascular Clinical Affairs

Study Description
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Brief Summary:

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.


Condition or disease
Brain Aneurysms

Study Design
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Study Type : Observational
Actual Enrollment : 793 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: International Retrospective Study of Pipeline Embolization Device
Study Start Date : March 2012
Actual Primary Completion Date : July 2013
Actual Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms

Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with brain aneurysms who were treated with the Pipeline Embolization Device
Criteria

Inclusion Criteria:

  • A patient who was treated with the Pipeline Embolization Device for treatment of a brain aneurysm
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01558102


Locations
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Sponsors and Collaborators
Medtronic Neurovascular Clinical Affairs
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier: NCT01558102    
Other Study ID Numbers: PED001
First Posted: March 20, 2012    Key Record Dates
Last Update Posted: November 25, 2013
Last Verified: November 2013
Keywords provided by Medtronic Neurovascular Clinical Affairs:
brain aneurysm PED Pipeline
Additional relevant MeSH terms:
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Intracranial Aneurysm
Aneurysm
Vascular Diseases
Cardiovascular Diseases
Intracranial Arterial Diseases
 Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases