IntrePED: International Retrospective Study of Pipeline Embolization Device
Sponsor
Medtronic Neurovascular Clinical Affairs (Industry)
Overall Status
Completed
CT.gov ID
NCT01558102
Collaborator
(none)
793
17
16
46.6
2.9
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
793 participants
Observational Model:
Case-Only
Time Perspective:
Retrospective
Official Title:
International Retrospective Study of Pipeline Embolization Device
Study Start Date
:
Mar 1, 2012
Actual Primary Completion Date
:
Jul 1, 2013
Actual Study Completion Date
:
Jul 1, 2013
Outcome Measures
Primary Outcome Measures
- 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.
Eligibility Criteria
Criteria
Ages Eligible for Study:
N/A
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- A patient who was treated with the Pipeline Embolization Device for treatment of a brain aneurysm
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Barrow Neurosurgical Associates | Phoenix | Arizona | United States | 85013 |
| 2 | Mayo Clinic | Jacksonville | Florida | United States | 32082 |
| 3 | Rush University Hospital | Chicago | Illinois | United States | 60612 |
| 4 | Norton Neuroscience Institute | Louisville | Kentucky | United States | 40241 |
| 5 | Abbott Northwestern Hospital | Minneapolis | Minnesota | United States | 55407 |
| 6 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
| 7 | University of Buffalo Neurosurgery, Buffalo General Hospital | Buffalo | New York | United States | 14203 |
| 8 | SUNY Stony Brook | Stony Brook | New York | United States | 11794 |
| 9 | Oregon Health & Science University | Portland | Oregon | United States | 97239 |
| 10 | Thomas Jefferson University | Philadelphia | Pennsylvania | United States | 19107 |
| 11 | Medical University of South Carolina | Charleston | South Carolina | United States | 29425 |
| 12 | Fort Sanders Regional Medical Center, Neurovascular Research | Knoxville | Tennessee | United States | 37916 |
| 13 | Clínica La Sagrada Familia | Buenos Aires | Argentina | C1426EOB | |
| 14 | Royal University Hospital | Saskatoon | Saskatchewan | Canada | S7N0W8 |
| 15 | Hôpital Gui de Chauliac | Montpellier | France | 34295 | |
| 16 | National Institute of Neurosciences | Budapest | Hungary | H-1145 | |
| 17 | A.O. Ospedale Niguarda Ca' Granda | Milan | Italy | 20162 |
Sponsors and Collaborators
- Medtronic Neurovascular Clinical Affairs
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Medtronic Neurovascular Clinical Affairs
ClinicalTrials.gov Identifier:
NCT01558102
Other Study ID Numbers:
- PED001
First Posted:
Mar 20, 2012
Last Update Posted:
Nov 25, 2013
Last Verified:
Nov 1, 2013
Keywords provided by Medtronic Neurovascular Clinical Affairs
Additional relevant MeSH terms: