International Retrospective Study of Pipeline Embolization Device (IntrePED)
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|ClinicalTrials.gov Identifier: NCT01558102|
Recruitment Status : Completed
First Posted : March 20, 2012
Last Update Posted : November 25, 2013
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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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||793 participants|
|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|
- 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.
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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|
- A patient who was treated with the Pipeline Embolization Device for treatment of a brain aneurysm
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
|Responsible Party:||Medtronic Neurovascular Clinical Affairs|
|Other Study ID Numbers:||
|First Posted:||March 20, 2012 Key Record Dates|
|Last Update Posted:||November 25, 2013|
|Last Verified:||November 2013|
brain aneurysm PED Pipeline
Intracranial Arterial Diseases
Central Nervous System Diseases
Nervous System Diseases