Study of the Penumbra Coil 400 System to Treat Aneurysm
Completed · Not applicable
Conditions studied: Intracranial Aneurysms, Peripheral Aneurysms
In brief
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 Penumbra Coil 400 (PC 400) System in the acute treatment of intracranial and peripheral aneurysms. Approximately 2,000 patients with intracranial or peripheral aneurysms treated by the PC 400 System at up to 100 centers will be enrolled. Data for each patient are collected up to discharge or 3 days post-procedure, whichever occurs sooner. Long term follow-up to one year will be conducted in accordance to the standard of care at each participating hospital.
Key facts
- Study ID
- NCT01465841
- Run by
- Penumbra Inc.
- People needed
- 517
- Starts
- 2011-11-01
- Expected to finish
- 2017-06-01
- Last updated by the study team
- 2020-07-07
Who can join
Age: any. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Hoag Hospital — Newport Beach, California, United States
- Rush University Medical Center — Chicago, Illinois, United States
- Mount Sinai School of Medicine — New York, New York, United States
- State University of New York Upstate Medical Center — Syracuse, New York, United States
- Fort Sanders Medical Center — Knoxville, Tennessee, United States
- The Methodist Hospital Research Institute — Houston, Texas, United States
Full record on ClinicalTrials.gov
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