Study of the Penumbra Coil 400 System to Treat Aneurysm
| Status: | Completed |
|---|---|
| Conditions: | Cardiology |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 12/6/2018 |
| Start Date: | November 2011 |
| End Date: | June 2017 |
ACE: An Aneurysm Coiling Efficiency Study of the Penumbra Coil 400 System
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.
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.
Inclusion Criteria:
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 Criteria:
- 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.
We found this trial at
6
sites
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Rush University Medical Center Rush University Medical Center encompasses a 664-bed hospital serving adults and...
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