Clinical trial NCT01558102: International Retrospective Study of Pipeline Embolization Device
Official title: International Retrospective Study of Pipeline Embolization Device
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Aneurysms
Keywords: brain aneurysm PED Pipeline
Lead sponsor: Medtronic Neurovascular Clinical Affairs
Sponsor class: INDUSTRY
First posted: 2012-03-20
Enrollment: 793
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with brain aneurysms who were treated with the 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.


Eligibility criteria: Inclusion Criteria:

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

Primary outcomes:
measure: Relative incidence of neurologic clinical events that occurred after treatment with PED
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Barrow Neurosurgical Associates
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic
state: Florida
city: Chicago
country: United States
facility: Rush University Hospital
state: Illinois
city: Louisville
country: United States
facility: Norton Neuroscience Institute
state: Kentucky
city: Minneapolis
country: United States
facility: Abbott Northwestern Hospital
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Buffalo
country: United States
facility: University of Buffalo Neurosurgery, Buffalo General Hospital
state: New York
city: Stony Brook
country: United States
facility: SUNY Stony Brook
state: New York
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Philadelphia
country: United States
facility: Thomas Jefferson University
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Knoxville
country: United States
facility: Fort Sanders Regional Medical Center, Neurovascular Research
state: Tennessee
city: Buenos Aires
country: Argentina
facility: Clínica La Sagrada Familia
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Montpellier
country: France
facility: Hôpital Gui de Chauliac
city: Budapest
country: Hungary
facility: National Institute of Neurosciences
city: Milan
country: Italy
facility: A.O. Ospedale Niguarda Ca' Granda
Study officials:
References:
citation: Park MS, Kilburg C, Taussky P, Albuquerque FC, Kallmes DF, Levy EI, Jabbour P, Szikora I, Boccardi E, Hanel RA, Bonafe A, McDougall CG. Pipeline Embolization Device with or without Adjunctive Coil Embolization: Analysis of Complications from the IntrePED Registry. AJNR Am J Neuroradiol. 2016 Jun;37(6):1127-31. doi: 10.3174/ajnr.A4678. Epub 2016 Jan 14.