This is a prospective, multi-center study of patients treated in accordance with the cleared indications for the Penumbra SMART CoilTM System (SMART), Penumbra Coil 400TM (PC 400), and Penumbra Occlusion DeviceTM (POD). Data for each patient are collected in accordance with the standard of care at each participating hospital through one-year follow-up. Approximately 1,000 patients with intracranial aneurysms or other malformations treated by the SMART CoilTM System at up to 100 centers will be enrolled. The primary objective of this registry is to gather post market data on the Penumbra SMART CoilTM System in the treatment of intracranial aneurysms and other malformation.
Local Principal Investigator: Richard Bellon, MD
For more information about this trial, please contact Alicia Drew, Director, Research and Physician Services at Radiology Imaging Associates.
If you would like to explore more clinical information about this trial, please see the trial page on ClinicalTrials.gov