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U.S. Department of Health and Human Services

Post-Approval Studies (PAS) Database

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The FDA has the authority to require sponsors to perform a post-approval study (or studies) at the time of approval of a premarket approval (PMA), humanitarian device exemption (HDE), or product development protocol (PDP) application. Post-approval studies can provide patients, health care professionals, the device industry, the FDA and other stakeholders information on the continued safety and effectiveness (or continued probable benefit, in the case of an HDE) of approved medical devices. This database allows you to search Post-Approval Study information by applicant or device information.

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Pipeline Flex Embolization w Shield Tech PAS


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General
Study Status Delayed
Application Number /
Requirement Number
P100018 S026/ PAS001
Date Original Protocol Accepted 07/19/2021
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
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.
Follow-up Visits and Length of Follow-up Patients will be followed for a minimum of 3 years.
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).
Actual Number of Patients Enrolled 217
Actual Number of Sites Enrolled 16
Patient Follow-up Rate Follow-up is on schedule. Three (3) patients were lost to follow-up.


Pipeline Flex Embolization w Shield Tech PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 10/12/2021 10/13/2021 Overdue/Received
1 year report 04/13/2022 04/11/2022 On Time
18 month report 10/12/2022 10/11/2022 On Time
2 year report 04/13/2023 04/13/2023 On Time
30 month report 10/13/2023 10/13/2023 On Time
3 year report 04/13/2024 04/12/2024 On Time
42 month report 10/13/2024 10/11/2024 On Time
4 year report 04/13/2025    


Contact Us

Mandated Studies Program
Food and Drug Administration
10903 New Hampshire Ave.
Silver Spring, MD 20993-0002
Email: MandatedStudiesPrograms@fda.hhs.gov

Additional Resources

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