NCT03873714

Pipeline™ Vantage Embolization Device With Shield Technology™ for Wide-Necked Intracranial Aneurysms (ADVANCE)

A Study of the Pipeline™ Vantage Embolization Device With Shield Technology™ for Endovascular Treatment of Wide-Necked Intracranial Aneurysms

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: Medtronic Neurovascular Clinical Affairs · Industry
• Sex: All
• Age: 22 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety and effectiveness of the Pipeline™ Vantage Embolization Device with Shield Technology™ in the treatment of intracranial aneurysms within the intended indication for use.

Detailed description

The safety of the Pipeline™ Vantage will be assessed through incidence of major stroke in the territory supplied by the treated artery or neurological death at 1-year post-procedure. The effectiveness of the Pipeline™ Vantage will be assessed through incidence of complete aneurysm occlusion (Raymond Roy Scale Class 1) without significant parent artery stenosis (≤ 50%) or retreatment of the target aneurysm at 1-year post-procedure. Additional safety and effectiveness analyses will include incidence of major stroke in the territory supplied by the treated artery or neurological death at 2- and 3-years post-procedure, incidence of major stroke in the territory supplied by the treated artery or neurological death at 30 days post-procedure, incidence of delayed intraparenchymal hemorrhage \>30 days post-procedure through 1-year post-procedure, incidence of subjects with disabling strokes that have a mRS decline to a score of 3 or more (mRS ≥ 3) due to a stroke-related cause assessed at a minimum of 90 days post-stroke event at 1 year, 2 year, and 3 year post-procedure, incidence of successful device implantation at the target site, incidence of complete aneurysm occlusion (Raymond Roy Class 1) at 1- and 3-years post-procedure, incidence of target aneurysm recurrence at 1- and 3-years post-procedure.

Conditions

• Intracranial Aneurysm

Interventions

Type	Name	Description
DEVICE	Pipeline™ Vantage Embolization Device with Shield Technology™	Pipeline™ Vantage Embolization Device with Shield Technology™

Timeline

• Start date: 2020-04-02
• Primary completion: 2021-07-22
• Completion: 2023-09-18
• First posted: 2019-03-13
• Last updated: 2025-06-19
• Results posted: 2024-09-05

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study