The primary objective of this study is to gather data on the radiation exposure in patients treated with the Penumbra Coil 400™ System (PC 400) or conventional coils per their respective indications for use.This is a multicenter case review study of patients presenting with intracranial aneurysms who are treated with coil embolization therapy using the PC 400 or conventional coils. Data for each patient are collected acutely.Up to 90 patients treated with the PC 400 or conventional coils (2:1) at up to 15 centers in the USA will be enrolled.
Study Type
OBSERVATIONAL
Enrollment
67
Overlake Hospital Medical Center
Bellevue, Washington, United States
1. Acute radiation exposure [air kerma, kerma-area product (KAP) or dose area product (DAP), and fluoroscopic time].
Radiation exposure is measured by air kerma, kerma-area product (KAP) or dose area product (DAP), and fluoroscopic time.
Time frame: At immediate post-procedure
2. Procedural serious adverse events
Time frame: Procedural serious adverse events up until 3 days or discharge, whichever occurs first.
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