International Retrospective Study of Pipeline Embolization Device
IntrePED
1 other identifier
observational
793
6 countries
17
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2012
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 8, 2012
CompletedFirst Posted
Study publicly available on registry
March 20, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedOctober 8, 2024
October 1, 2024
1.3 years
March 8, 2012
October 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Eligibility Criteria
Patients with brain aneurysms who were treated with the Pipeline Embolization Device
You may qualify if:
- A patient who was treated with the Pipeline Embolization Device for treatment of a brain aneurysm
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Barrow Neurosurgical Associates
Phoenix, Arizona, 85013, United States
Mayo Clinic
Jacksonville, Florida, 32082, United States
Rush University Hospital
Chicago, Illinois, 60612, United States
Norton Neuroscience Institute
Louisville, Kentucky, 40241, United States
Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407, United States
Mayo Clinic
Rochester, Minnesota, 55905, United States
University of Buffalo Neurosurgery, Buffalo General Hospital
Buffalo, New York, 14203, United States
SUNY Stony Brook
Stony Brook, New York, 11794, United States
Oregon Health & Science University
Portland, Oregon, 97239, United States
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
Fort Sanders Regional Medical Center, Neurovascular Research
Knoxville, Tennessee, 37916, United States
Clínica La Sagrada Familia
Buenos Aires, C1426EOB, Argentina
Royal University Hospital
Saskatoon, Saskatchewan, S7N0W8, Canada
Hôpital Gui de Chauliac
Montpellier, 34295, France
National Institute of Neurosciences
Budapest, H-1145, Hungary
A.O. Ospedale Niguarda Ca' Granda
Milan, 20162, Italy
Related Publications (1)
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.
PMID: 26767709DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 8, 2012
First Posted
March 20, 2012
Study Start
March 1, 2012
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
October 8, 2024
Record last verified: 2024-10