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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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FRED X PAS


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General
Study Status Progress Adequate
Application Number /
Requirement Number
P180027 S002/ PAS001
Date Original Protocol Accepted 04/26/2022
Date Current Protocol Accepted  
Study Name FRED X PAS
Device Name Flow Re-Direction Endoluminal Device (FRED®) System
General Study Protocol Parameters
Study Design Prospective Cohort Study
Data Source New Data Collection
Comparison Group Historical Control
Analysis Type Analytical
Study Population Adult: >21
Detailed Study Protocol Parameters
Study Objectives The objective of the study is to collect clinical data to compare the performance of the FRED X System with the performance of the FRED System. To achieve the objective, this study will evaluate the safety and effectiveness outcomes of FRED X System in a population of patients that aligns with the indications for use of the FRED System.

The study is a prospective, adaptive, multicenter, single-arm study with follow-up at discharge, 30 days (+/-7 days), 6 months (+/-30 days), 12 months (+60 days/-30 days), 2 years (+/-60 days), 3 years (+/-60 days), and 5 years (+/-60 days).
Study Population Adult patients with intracranial aneurysms (IA) of the internal carotid artery from the petrous segment to the terminus with wide-necked (neck width greater than or equal to 4mm or dome-to-neck ratio <2) saccular or fusiform intracranial aneurysms arising from a parent vessel with a diameter greater than or equal to 2.0 mm and less than or equal to 5.0 mm.
Sample Size 140 subjects (154 with 10% attrition).

Based on a type 1 and 2 error rates of 2.5% and 10% respectively, 140 patients would be required to reject the null hypothesis in favor of the alternative, assuming 60% of patients who meet the primary effectiveness outcome. Assuming a loss to follow-up of about 10% in this population, the recruited sample size will be 154 subjects.
Key Study Endpoints Primary Effectiveness Outcome
The percent of subjects with successful aneurysm treatment as defined by complete occlusion (100%) of the target aneurysm and less than or equal to 50% stenosis of the parent artery at the target IA at 12 months and in whom an alternate treatment of the target IA had not been performed within 12 months post-FRED X Device placement.

Primary Safety Outcome
Death or major stroke within 30 days post-procedure.
Neurological death or major ipsilateral stroke within 12 months post-procedure.

Secondary Outcomes
Proportion of subjects with clinically acceptable (90% – 100%) occlusion of the target aneurysm, less than or equal to 50% stenosis of the parent artery at the target IA at the 12-month, 2-year, 3-year and 5-year follow-up visits, and in whom an unplanned alternative treatment of the target IA had not been performed within the follow-up period.
Incidence of >50% in-stent stenosis (ISS) at the target IA at the 12-month, 2-year, 3-year and 5-year follow-up visits.
Proportion of subjects with complete occlusion of the target aneurysm at the 12-month, 2-year, 3-year, and 5-year follow-up.
Proportion of subjects with clinically acceptable (90% – 100%) occlusion of the target aneurysm at the 12-month, 2-year, 3-year, and 5-year follow-up.
Incidence of FRED X System procedure-related serious adverse events (SAEs) through the end of the study.
Incidence of FRED X System device-related SAEs through the end of the study.
Incidence of unsuccessful delivery or deployment of the FRED X System.
Incidence of migration of the FRED X System implant at 12-month follow-up visit.
Incidence of change in clinical and functional outcomes at 6-month, 12-month, 2-year, 3-year, and 5-year follow-up, as measured by an increase in the modified Rankin Scale compared to baseline.
Incidence of major stroke, as measured by NIHSS for all the follow-up visits (and ophthalmic examination related to the target aneurysm if determined appropriate).
Incidence of minor stroke, as measured by NIHSS for all follow-up visits (and ophthalmic examination related to the target aneurysm if determined appropriate).

Follow-up Visits and Length of Follow-up 5 years


FRED X PAS Reporting Schedule

Reporting Schedule
Report
Date Due
FDA Receipt
Date
Applicant's Reporting Status
6 month report 03/17/2022 04/25/2022 Overdue/Received
1 year report 09/16/2022 09/19/2022 Overdue/Received
18 month report 03/17/2023    
2 year report 09/16/2023    
3 year report 09/15/2024    


Contact Us

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

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