INSPIRE Pipeline™ Shield Post Approval Study

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05071963
Study type	Observational [Patient Registry]
Source	Medtronic Neurovascular Clinical Affairs
Contact	Medtronic Neurovascular Clinical Affairs
Phone	949-837-3700
Email	rs.shieldpostapproval@medtronic.com
Status	Recruiting
Phase
Start date	December 20, 2021
Completion date	March 2027

View Details

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