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General |
Study Status |
Delayed |
Application Number / Requirement Number |
P100018 S026/ PAS001 |
Date Original Protocol Accepted |
07/19/2021
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Date Current Protocol Accepted |
 
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Study Name |
Pipeline Flex Embolization w Shield Tech PAS
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Device Name |
Pipeline Flex Embolization Device with Shield Technology
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General Study Protocol Parameters |
Study Design |
Prospective Cohort Study
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Data Source |
Sponsor Registry
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Comparison Group |
Objective Performance Criterion
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Analysis Type |
Analytical
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Detailed Study Protocol Parameters |
Study Objectives |
Prospective cohort. Will use sponsor’s “Product Surveillance Registry” platform.
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Study Population |
Adult patients receiving Pipeline Flex Embolization Device with Shield Technology for treatment of intracranial aneurysm.
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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 cut off date of 11-SEPTEMBER-2024, there have been no unanticipated adverse events (AEs). Eighty-three (83) AEs have been adjudicated by the CEC and a listing of the data is included in Annex B. A summary of CEC-Adjudicated Neurological Adverse Events of Interest Post-Procedure (up to 1 year, >1 year) is presented in Table 12. There has been one (1) reported non-neurological death, pending CEC adjudication. There have been nine (9) non-disabling strokes (eight (8) minor strokes and one (1) indeterminate stroke) and four (4) intra-cranial hemorrhage (ICH). Two (2) patient narratives describing endpoint-related adverse events (patients 6088010 and 2944017), one (1) patient narrative describing a patient (3242013) who experienced two (2) ICH events and one (1) patient narrative regarding non-neurological death (patient 2944006), are presented within Annex E. A listing of site-reported AE data is included in Annex B.
Effectiveness Results: As of the data cut off date of 11-SEPTEMBER-2024, the following data was entered and available in the database: 1) implant and device deployment success of two hundred eight (208) patients, 2) Core Lab reported post-procedure imaging outcomes of one hundred eighty-nine (189) patients, 3) Core Lab reported six (6) month follow-up imaging of one hundred twenty-three (123) patients, 4) Core Lab reported one (1) year follow-up imaging of sixty-eight (68) patients, 5) modified Rankin Scale (mRS) clinical outcome scores at baseline, 180-day follow-up, 1-year and 3-year follow-up for one hundred ninety-eight (198), one hundred twelve (112), seventy-three (73) and one (1) patient(s) respectively, and 6) all available CEC (clinical events committee)-adjudicated adverse events (AEs).
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Actual Number of Patients Enrolled |
217
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Actual Number of Sites Enrolled |
16
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Patient Follow-up Rate |
Follow-up is on schedule. Three (3) patients were lost to follow-up.
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