Purpose Radiation exposure during an angiographic procedure may present a significant health risk to patients. The goal of this multicenter case study (CARE) is to compare such exposure in patients treated with the novel Penumbra Coil 400™ System (PC 400) vs. conventional coils. The PC 400 coils are a new generation of platinum embolic coils designed specifically to enhance filling efficiency, which can allow faster procedure times. This could lead to less radiation exposure than with conventional coils in comparable size aneurysms.
Methods CARE will enrol up to 90 patients, including the control group, presenting with intracranial aneurysms at 15 centers in the USA. They will receive coil embolization therapy with the PC 400 or conventional coils (2:1) in accordance with the cleared indications for use. Adjunctive use of stents, balloons or liquid embolics is permitted. The primary endpoints are: 1) Acute radiation exposure at immediate post-procedure [air kerma, kerma-area product (KAP) or dose area product (DAP), and fluoroscopic time]; 2) Procedural serious adverse events up until 3 days or discharge, whichever occurs first.
Results It is predicted that patient enrollment will require 12 months. Patients will be monitored and assessed until 3 days after the coiling procedure or discharge from the hospital (whichever occurs first). IRB approval is pending for this study.
Conclusion Limited literature is available about treatment-related radiation exposure in patients treated by the PC 400. We hypothesise that due to the unique large volume of these coils, procedural time for embolic coiling of intracranial aneurysms may be shortened over conventional coils, leading to significantly lower radiation exposure.
Disclosures A. Chowdhary: None.
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