A Study of the Pipeline™ Vantage Embolization Device With Shield Technology™ for Endovascular Treatment of Wide-Necked Intracranial Aneurysms
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intracranial Aneurysm
- Sponsor
- Medtronic Neurovascular Clinical Affairs
- Enrollment
- 140
- Locations
- 3
- Primary Endpoint
- Safety: Incidence of Major Stroke or Neurological Death
- Status
- Terminated
- Last Updated
- 10 months ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Safety: Incidence of Major Stroke or Neurological Death
Time Frame: 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
Time Frame: 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 Outcomes
- Effectiveness: Incidence of Successful Device Implantation(Day 0)
- Effectiveness: Incidence of Complete Aneurysm Occlusion(3 years post-procedure)
- Effectiveness: Incidence of Target Aneurysm Recurrence(3 years post-procedure)
- Safety: Incidence of Major Stroke(30 days post-procedure)
- Safety: 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)