INSPIRE Pipeline™ Shield Post Approval Study
NCT05071963 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 246
Last updated 2026-02-27
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.
Conditions
- Intracranial Aneurysm
Interventions
- DEVICE
-
Treatment of Intracranial Aneurysms
Embolization of aneurysms using the Pipeline™ Flex Embolization Device with Shield Technology™
Sponsors & Collaborators
-
Medtronic Neurovascular Clinical Affairs
lead INDUSTRY
Principal Investigators
-
Harsh Sancheti · Medtronic
Eligibility
- Min Age
- 22 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-12-20
- Primary Completion
- 2026-07-31
- Completion
- 2028-04-30
- FDA Device
- Yes
Countries
- United States
Study Locations
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