International Retrospective Study of Pipeline Embolization Device

Brain Aneurysms Clinical Trial

— IntrePED  

Official title:

International Retrospective Study of Pipeline Embolization Device

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01558102
• Other study ID #: PED001
• Status: Completed
• Phase: N/A
• First received: March 8, 2012
• Last updated: November 20, 2013
• Start date: March 2012
• Est. completion date: July 2013

Study information

• Verified date: November 2013
• Source: ev3
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 793
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Brain Aneurysms

Locations

Country	Name	City	State
Argentina	Clínica La Sagrada Familia	Buenos Aires
Canada	Royal University Hospital	Saskatoon	Saskatchewan
France	Hôpital Gui de Chauliac	Montpellier
Hungary	National Institute of Neurosciences	Budapest
Italy	A.O. Ospedale Niguarda Ca' Granda	Milan
United States	University of Buffalo Neurosurgery, Buffalo General Hospital	Buffalo	New York
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Rush University Hospital	Chicago	Illinois
United States	Mayo Clinic	Jacksonville	Florida
United States	Fort Sanders Regional Medical Center, Neurovascular Research	Knoxville	Tennessee
United States	Norton Neuroscience Institute	Louisville	Kentucky
United States	Abbott Northwestern Hospital	Minneapolis	Minnesota
United States	Thomas Jefferson University	Philadelphia	Pennsylvania
United States	Barrow Neurosurgical Associates	Phoenix	Arizona
United States	Oregon Health & Science University	Portland	Oregon
United States	Mayo Clinic	Rochester	Minnesota
United States	SUNY Stony Brook	Stony Brook	New York

Sponsors (1)

Lead Sponsor	Collaborator
ev3

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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.	Yes