Status:
COMPLETED
Study of the Penumbra Coil 400 System to Treat Aneurysm
Lead Sponsor:
Penumbra Inc.
Conditions:
Intracranial Aneurysms
Peripheral Aneurysms
Eligibility:
All Genders
Phase:
NA
Brief Summary
This is a prospective, multi-center study of patients with intracranial or peripheral aneurysms who are treated by the PC 400 System. The primary objective is to gather post market data on the Penumbr...
Eligibility Criteria
Inclusion
- Patients enrolled in this study must be those treated according to the cleared indication for the PC 400 System which is for the endovascular embolization of:
- Intracranial aneurysms
- Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
- Arterial and venous embolizations in the peripheral vasculature
Exclusion
- Patients in whom endovascular embolization therapies other than Penumbra Coils are used will be excluded from this study. However, adjunctive use of balloon and stent are acceptable.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
517 Patients enrolled
Trial Details
Trial ID
NCT01465841
Start Date
November 1 2011
End Date
June 1 2017
Last Update
July 7 2020
Active Locations (6)
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1
Hoag Hospital
Newport Beach, California, United States, 92658-6100
2
Rush University Medical Center
Chicago, Illinois, United States, 60612-3833
3
Mount Sinai School of Medicine
New York, New York, United States, NY 10029
4
State University of New York Upstate Medical Center
Syracuse, New York, United States, 13210