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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
Pipeline™ Vantage Embolization Device with Shield Technology™
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
Safety: Incidence of Major Stroke or Neurological Death
Incidence of major stroke in the territory supplied by the treated artery or neurological death.
Time frame: 1 year post-procedure
Effectiveness: Incidence of Complete Aneurysm Occlusion
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.
Time frame: 1 year post-procedure
Effectiveness: Incidence of Successful Device Implantation
Incidence of successful device implantation at the target site
Time frame: Day 0
Effectiveness: Incidence of Complete Aneurysm Occlusion
Incidence of complete aneurysm occlusion (Raymond Roy Class 1)
Time frame: 1 year post-procedure
Effectiveness: Incidence of Target Aneurysm Recurrence
Incidence of target aneurysm recurrence at 1 year post-procedure
Time frame: 1 year post-procedure
Safety: Incidence of Major Stroke
Incidence of major stroke in the territory supplied by the treated artery or neurological death
Time frame: 2 and 3 years post-procedure
Safety: Incidence of Major Stroke
Incidence of major stroke in the territory supplied by the treated artery or neurological death
Time frame: 30 days post-procedure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Safety: Incidence of Delayed Intraparenchymal Hemorrhage
Incidence of delayed intraparenchymal hemorrhage \>30 days post-procedure through 1-year post-procedure
Time frame: >30 days post-procedure through 1 year post-procedure
Safety: Incidence of Subjects With Disabling Strokes
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
Time frame: Assessed from procedure through 3 years post-procedure
Effectiveness: Incidence of Complete Aneurysm Occlusion
Incidence of complete aneurysm occlusion (Raymond Roy Class 1)
Time frame: 3 years post-procedure
Effectiveness: Incidence of Target Aneurysm Recurrence
Incidence of target aneurysm recurrence 3-years post-procedure
Time frame: 3 years post-procedure