International Retrospective Study of Pipeline Embolization Device

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01558102

Acronym

IntrePED

Enrollment

793

Registered

2012-03-20

Start date

2012-03-31

Completion date

2013-07-31

Last updated

2024-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain Aneurysms

Keywords

brain aneurysm PED Pipeline

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame	Description
Relative incidence of neurologic clinical events that occurred after treatment with PED	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.

Countries

Argentina, Canada, France, Hungary, Italy, United States

Outcome results