NCT06604884

NV PSR INSPIRE-A Pipeline™ Vantage Post Approval Study

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 118 (estimated)
• Sponsor: Medtronic Neurovascular Clinical Affairs · Industry
• Sex: All
• Age: 22 Years
• Healthy volunteers: —

Summary

The purpose of the Pipeline™ Vantage Embolization Device with Shield Technology™ Post Approval Study (PAS) ("Pipeline™ Vantage PAS") is to collect safety and effectiveness data in patients undergoing treatment for intracranial aneurysms (IA) using the Pipeline™ Vantage Embolization Device with Shield Technology™ ("Pipeline™ Vantage Device") in a post approval setting.

Detailed description

The INSPIRE Pipeline™ Vantage Post Approval Study is a, prospective, multi-center, single-arm clinical study to collect safety and effectiveness data in patients undergoing treatment for intracranial aneurysms using the Pipeline™ Vantage Embolization Device with Shield Technology™. This study is a sub-study to the Neurovascular Product Surveillance Registry (NCT02988128).

Conditions

• Intracranial Aneurysm

Interventions

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

Timeline

• Start date: 2025-12-12
• Primary completion: 2029-08-01
• Completion: 2033-09-01
• First posted: 2024-09-20
• Last updated: 2026-04-02

Locations

4 sites across 1 country: United States

Regulatory

• FDA-regulated device study