International Retrospective Study of Pipeline Embolization Device (IntrePED)
This study is enrolling participants by invitation only.
Sponsor:
ev3
Information provided by (Responsible Party):
ev3
ClinicalTrials.gov Identifier:
NCT01558102
First received: March 8, 2012
Last updated: March 12, 2013
Last verified: March 2013
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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.
| Estimated Enrollment: | 1000 |
| Study Start Date: | March 2012 |
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
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: | March 12, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by ev3:
|
brain aneurysm PED Pipeline |
Additional relevant MeSH terms:
|
Aneurysm Intracranial Aneurysm Vascular Diseases Cardiovascular Diseases Intracranial Arterial Diseases |
Cerebrovascular Disorders Brain Diseases Central Nervous System Diseases Nervous System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013