International Retrospective Study of Pipeline Embolization Device (IntrePED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ev3
ClinicalTrials.gov Identifier:
NCT01558102
First received: March 8, 2012
Last updated: November 20, 2013
Last verified: November 2013
  Purpose

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.


Condition
Brain Aneurysms

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: International Retrospective Study of Pipeline Embolization Device

Resource links provided by NLM:


Further study details as provided by ev3:

Primary Outcome Measures:
  • Relative incidence of neurologic clinical events that occurred after treatment with PED [ 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. ] [ Designated as safety issue: Yes ]
    Incidence of neurologic events from the time of Approval of the Pipeline Embolization Device in the country of use until IRB approval at facility.


Enrollment: 793
Study Start Date: March 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients with brain aneurysms who were treated with the Pipeline Embolization Device

Criteria

Inclusion Criteria:

  • A patient who was treated with the Pipeline Embolization Device for treatment of a brain aneurysm
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01558102

Locations
United States, Arizona
Barrow Neurosurgical Associates
Phoenix, Arizona, United States, 85013
United States, Florida
Mayo Clinic
Jacksonville, Florida, United States, 32082
United States, Illinois
Rush University Hospital
Chicago, Illinois, United States, 60612
United States, Kentucky
Norton Neuroscience Institute
Louisville, Kentucky, United States, 40241
United States, Minnesota
Abbott Northwestern Hospital
Minneapolis, Minnesota, United States, 55407
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, New York
University of Buffalo Neurosurgery, Buffalo General Hospital
Buffalo, New York, United States, 14203
SUNY Stony Brook
Stony Brook, New York, United States, 11794
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Pennsylvania
Thomas Jefferson University
Philadelphia, Pennsylvania, United States, 19107
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Fort Sanders Regional Medical Center, Neurovascular Research
Knoxville, Tennessee, United States, 37916
Argentina
Clínica La Sagrada Familia
Buenos Aires, Argentina, C1426EOB
Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N0W8
France
Hôpital Gui de Chauliac
Montpellier, France, 34295
Hungary
National Institute of Neurosciences
Budapest, Hungary, H-1145
Italy
A.O. Ospedale Niguarda Ca' Granda
Milan, Italy, 20162
Sponsors and Collaborators
ev3
  More Information

No publications provided

Responsible Party: ev3
ClinicalTrials.gov Identifier: NCT01558102     History of Changes
Other Study ID Numbers: PED001
Study First Received: March 8, 2012
Last Updated: November 20, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by ev3:
brain aneurysm PED Pipeline

Additional relevant MeSH terms:
Aneurysm
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014