NCT05071963

INSPIRE Pipeline™ Shield Post Approval Study

Neurovascular Product Surveillance Registry (INSPIRE) Pipeline™ Flex Embolization Device With Shield Technology™ Post Approval Study (PAS)

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 246 (actual)
• Sponsor: Medtronic Neurovascular Clinical Affairs · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Intracranial Aneurysm

Interventions

Type	Name	Description
DEVICE	Treatment of Intracranial Aneurysms	Embolization of aneurysms using the Pipeline™ Flex Embolization Device with Shield Technology™

Timeline

• Start date: 2021-12-20
• Primary completion: 2026-07-01
• Completion: 2028-04-01
• First posted: 2021-10-08
• Last updated: 2026-02-27

Locations

16 sites across 1 country: United States

Regulatory

• FDA-regulated device study