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

Not Applicable

Terminated

Interventions: Device: Pipeline™ Vantage Embolization Device with Shield Technology™

Brief 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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Pipeline™ Vantage Embolization Device with Shield Technology™	Pipeline™ Vantage Embolization Device with Shield Technology™	Pipeline™ Vantage Embolization Device with Shield Technology™

Primary Outcome Measures

Name	Time	Method
Safety: Incidence of Major Stroke or Neurological Death	1 year post-procedure	Incidence of major stroke in the territory supplied by the treated artery or neurological death.
Effectiveness: Incidence of Complete Aneurysm Occlusion	1 year post-procedure	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.

Secondary Outcome Measures

Name	Time	Method
Effectiveness: Incidence of Successful Device Implantation	Day 0	Incidence of successful device implantation at the target site
Effectiveness: Incidence of Complete Aneurysm Occlusion	3 years post-procedure	Incidence of complete aneurysm occlusion (Raymond Roy Class 1)
Effectiveness: Incidence of Target Aneurysm Recurrence	3 years post-procedure	Incidence of target aneurysm recurrence 3-years post-procedure
Safety: Incidence of Major Stroke	30 days post-procedure	Incidence of major stroke in the territory supplied by the treated artery or neurological death
Safety: Incidence of Delayed Intraparenchymal Hemorrhage	>30 days post-procedure through 1 year post-procedure	Incidence of delayed intraparenchymal hemorrhage \>30 days post-procedure through 1-year post-procedure
Safety: Incidence of Subjects With Disabling Strokes	Assessed from procedure through 3 years 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

Locations (3): Baptist Medical Center Jacksonville
🇺🇸
Jacksonville, Florida, United States
Jackson Memorial Hospital
🇺🇸
Miami, Florida, United States
Stony Brook University Hospital
🇺🇸
Stony Brook, New York, United States