International Retrospective Study of Pipeline Embolization Device
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 793
- Locations
- 16
- Primary Endpoint
- Relative incidence of neurologic clinical events that occurred after treatment with PED
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Retrospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •A patient who was treated with the Pipeline Embolization Device for treatment of a brain aneurysm
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported