Approval Date: 4/13/2012
Principal Investigator: Chris Kazmierczak, MD
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.
Each study has its own guidelines to determine who can participate, called "eligibility criteria", with only the study doctor able to assess whether you meet all of the eligibility criteria. More information can be found at http://clinicaltrials.gov/ct2/show/NCT01465841.
Brian Walker, RN, Research Coordinator
Status of Clinical Trial:
open and enrolling