Research Study Summary
A clinical trial to evaluate treatments using PC 400 coils (Penumbra ) for patients with Intracranial Aneurysms or Peripheral Aneurysms
Research Study Title
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.
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