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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P180027 S002/ PAS001 |
| Date Original Protocol Accepted |
04/26/2022
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| Date Current Protocol Accepted |
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| Study Name |
FRED X PAS
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| Device Name |
Flow Re-Direction Endoluminal Device (FRED®) System
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
New Data Collection
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| Comparison Group |
Historical Control
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| Analysis Type |
Analytical
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| Study Population |
Adult: >21
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| 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).
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| 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.
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| 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.
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| 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).
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| Follow-up Visits and Length of Follow-up |
5 years
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| Interim or Final Data Summary |
| Interim Results |
29 adverse events
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| Actual Number of Patients Enrolled |
29
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| Actual Number of Sites Enrolled |
18
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| Final Effect Findings |
N/A
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