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|
| General |
| Study Status |
Study Pending |
Application Number /
Requirement Number |
P100018 S034/ PAS001 |
| Date Original Protocol Accepted |
06/06/2024
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| Date Current Protocol Accepted |
|
| Study Name |
INSPIRE Pipeline Vantage Embolization Device PAS
|
| Device Name |
Pipeline Vantage Embolization Device with Shield Technology
|
| Clinical Trial Number(s) |
NCT03873714
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
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| Study Population |
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
Objective: The purpose of the Pipeline Vantage Embolization Device with Shield Technology Post Approval Study (PAS)
(“Pipeline Vantage PAS”) is to collect safety and effectiveness data in patients undergoing treatment for intracranial aneurysms
(IA) using the Pipeline™ Vantage Embolization Device with Shield Technology (“Pipeline Vantage Device”) in a post approval
setting.
Design: Prospective cohort. Will use sponsor’s “Product Surveillance Registry” platform.
|
| Study Population |
Adult patients that will be treated for intracranial aneurysms using the Pipeline Vantage device.
|
| Sample Size |
215 enrolled with expected 15% dropout. It is expected that there will be 182 evaluable subjects with power of 0.80.
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| Key Study Endpoints |
Key safety outcomes:
Assessment of all intracranial ischemic and hemorrhagic events
Composite of the incidence of major stroke in the territory supplied by the treated artery or neurological death evaluated within 1-, 3-, and 5-years of the index procedure.
Incidence of patients with disabling strokes that have a mRS decline to a score of 3 or more (mRS greater than or equal to 3) due to a stroke-related cause assessed at a minimum of 90 days post-stroke event within 1-, 3-, and 5-years of the index procedure.
Incidence of target aneurysm rupture through 5-years of the index procedure
All serious adverse events
Key effectiveness outcomes:
Composite of complete occlusion of the target intracranial aneurysm (Raymond-Roy I) without significant parent artery stenosis (= 50%) nor retreatment of the target intracranial aneurysm at 1-, 3-, and 5-years of the index procedure
o Each component of the composite outcome (occlusion status, incidence of parent artery stenosis and incidence of retreatment) will also be
presented separately at all three follow-ups (at 1, 3 and 5 years of the index procedure)
Implant success rate at the target site Implant success rate (device level)1
Implant success rate (patient level)2
Number of devices implanted
Pipeline™ Vantage Device usability evaluation with objective scoring criteria (during the procedure) 3
1Device level analysis providing the rate of successful
Pipeline™ Vantage Device implantations at the target site with the total number of Pipeline Vantage Devices attempted to be deployed.
2Percentage of patients with successful device implant(s).
3Usability will be evaluated by neurointerventionalists based on the following assessment factors with objective scoring
criteria (per the definitions in the Device Usability section of the Procedure CRF): successful implantation, implantation
time, device delivery, deployment, resheathing, visibility and overall performance.
Each factor will be evaluated based on whether the
neurointerventionalist in a clinical setting found the
device usability acceptable or unacceptable.Objective scoring criteria
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| Follow-up Visits and Length of Follow-up |
Patients will be followed for a minimum of 5 years.
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