Pipeline™ Vantage Embolization Device With Shield Technology™ for Wide-Necked Intracranial Aneurysms (ADVANCE)
- Conditions
- Intracranial Aneurysm
- Registration Number
- NCT03873714
- Lead Sponsor
- Medtronic Neurovascular Clinical Affairs
- 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
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 140
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- 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
Trial Locations
- 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
Baptist Medical Center Jacksonville🇺🇸Jacksonville, Florida, United States