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|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P100018 S026/ PAS001 |
| Date Original Protocol Accepted |
07/19/2021
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| Date Current Protocol Accepted |
|
| Study Name |
Pipeline Flex Embolization w Shield Tech PAS
|
| Device Name |
Pipeline Flex Embolization Device with Shield Technology
|
| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
|
| Data Source |
Sponsor Registry
|
| Comparison Group |
Objective Performance Criterion
|
| Analysis Type |
Analytical
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Prospective cohort. Will use sponsor’s “Product Surveillance Registry” platform.
|
| Study Population |
Adult patients receiving Pipeline Flex Embolization Device with Shield Technology for treatment of intracranial aneurysm.
|
| Sample Size |
203
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| Key Study Endpoints |
Primary Endpoint: A patient will be considered a success if there is complete occlusion of the target aneurysm without significant parent artery stenosis (less than or equal to 50%), and the patient does not require retreatment of the target aneurysm.
Secondary Endpoints:
1. Incidence of complete aneurysm occlusion (defined as Raymond-Roy Class 1) without significant parent artery stenosis (less than or equal to 50%) or retreatment of the target aneurysm through 1- and 3-years post-procedure.
2. Incidence of device deployment success rate at the target site.
3. Incidence of target aneurysm recurrence and retreatment through 1- and 3- year post-procedure.
4. Incidence of major stroke in the territory supplied by the treated artery or neurological death through 3-years post-procedure.
5. Incidence of major stroke in the territory supplied by the treated artery or neurological death through 30 days post-procedure due to procedural complications.
6. Incidence of delayed intracerebral hemorrhage > 30 days through 1- and 3- years post-procedure.
7. Incidence of patients 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- and 3-years post-procedure.
8. Incidence of all strokes, both hemorrhagic and ischemic, through 1- and 3-years post-procedure.
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| Follow-up Visits and Length of Follow-up |
Patients will be followed for a minimum of 3 years.
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| Interim or Final Data Summary |
| Interim Results |
Safety Results
As of the data cutoff date of 19-SEPTEMBER-2023, There have been no reported deaths. There have been seven (7) non-disabling, minor strokes and two (2) intra-cranial hemorrhage (ICH). Nine (9) serious adverse events (SAEs) are reported to have possible or causal relationship with the device.
Effectiveness Results
As of the data cutoff date of 19-SEPTEMBER-2023, at end of procedure, 6-Month and 1-Year follow-up, complete occlusion was reported in pending response to deficiency.
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| Actual Number of Patients Enrolled |
102
|
| Actual Number of Sites Enrolled |
12
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| Patient Follow-up Rate |
Follow-up is on schedule. Five subjects lost to follow-up as of this reporting period.
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