International Retrospective Study of Pipeline Embolization Device

Medtronic Neurovascular Clinical Affairs793 enrolled

Overview

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 Type

OBSERVATIONAL

Enrollment

793

Conditions

Brain Aneurysms

Eligibility

Sex: ALL

Medical Language ↔ Plain English

Inclusion Criteria: * A patient who was treated with the Pipeline Embolization Device for treatment of a brain aneurysm

Locations (17)

Barrow Neurosurgical Associates

Phoenix, Arizona, United States

Mayo Clinic

Jacksonville, Florida, United States

Outcomes

Primary Outcomes

Relative incidence of neurologic clinical events that occurred after treatment with PED

Incidence of neurologic events from the time of Approval of the Pipeline Embolization Device in the country of use until IRB approval at facility.

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.

Data from ClinicalTrials.gov

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