International Retrospective Study of Pipeline Embolization Device (IntrePED)

This study is enrolling participants by invitation only.

Sponsor:

Information provided by (Responsible Party):

ev3

ClinicalTrials.gov Identifier:

NCT01558102

First received: March 8, 2012

Last updated: March 12, 2013

Last verified: March 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	March 8, 2012
Last Updated Date	March 12, 2013
Start Date ^ICMJE	March 2012
Primary Completion Date	Not Provided
Current Primary Outcome Measures ^ICMJE (submitted: March 16, 2012)	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. ] [ Designated as safety issue: Yes ] Incidence of neurologic events from the time of Approval of the Pipeline Embolization Device in the country of use until IRB approval at facility.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01558102 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	International Retrospective Study of Pipeline Embolization Device
Official Title ^ICMJE	International Retrospective Study of Pipeline Embolization Device
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.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case-Only Time Perspective: Retrospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Patients with brain aneurysms who were treated with the Pipeline Embolization Device
Condition ^ICMJE	Brain Aneurysms
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Enrolling by invitation
Estimated Enrollment ^ICMJE	1000
Completion Date	Not Provided
Primary Completion Date	Not Provided
Eligibility Criteria ^ICMJE	Inclusion Criteria: A patient who was treated with the Pipeline Embolization Device for treatment of a brain aneurysm
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States, Argentina, Canada, France, Hungary, Italy

Administrative Information
NCT Number ^ICMJE	NCT01558102
Other Study ID Numbers ^ICMJE	PED001
Has Data Monitoring Committee	No
Responsible Party	ev3
Study Sponsor ^ICMJE	ev3
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	ev3
Verification Date	March 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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