Study of the Pipeline Flex Embolization Device with Shield Technology for Treating Wide-Necked Intracranial Aneurysms in Adults

What this Trial Is About

Researchers are evaluating the Pipeline22 Flex Embolization Device with Shield Technology22 for treating adults aged 22 years and older who have large or giant wide-necked intracranial aneurysms in specific parts of the internal carotid artery. This device is also studied for smaller wide-necked aneurysms arising from parent vessels of certain sizes. The study aims to collect clinical evidence on the approved use of this device for endovascular treatment of these aneurysms. Participants will receive treatment with the Pipeline SHIELD Device, which is a flow diverter technology designed to manage intracranial aneurysms. The treatment involves endovascular placement of the device in the affected artery segments as specified. There is one study arm using this active treatment device. The study does not involve masking or blinding. During the study, participants will be monitored for the occurrence of thromboembolic events over a 12-month period. Researchers will evaluate safety outcomes related to these events. The overall study period spans from the start date in 2025 through an observation of outcomes up to 12 months after treatment. Participants will be adults able to provide consent or have a legally authorized representative available.

Evaluation of Flow Diverter Technology Device for Intracranial Aneurysm (SHIELD)