The INSPIRE Pipeline™ Shield Post Approval Study is an observational, prospective, multi-center, single-arm registry to collect on-label use data in patients undergoing treatment for intracranial aneurysms using the Pipeline™ Flex Embolization Device with Shield Technology™ according to the intended use.~The primary objective of this study is to evaluate the on-label use of the Pipeline™ Shield Device in patients undergoing treatment for intracranial aneurysms per institutional routine clinical care in a real-world post approval study setting in the U.S.~This study is conducted under the Product Surveillance Registry (NCT01524276) and is a sub-study to the therapy specific Neurovascular Product Surveillance Registry (NCT02988128).
The purpose of the Pipeline™ Flex Embolization Device with Shield Technology™ Post Approval Study (PAS) (Pipeline™ Shield PAS) is to collect on-label use data in patients undergoing treatment for intracranial aneurysms (IA) using the Pipeline™ Flex Embolization Device with Shield Technology™ (Pipeline™ Shield Device) in a real-world post approval setting within the United States.