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|
| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P180027 S002/ PAS001 |
| Date Original Protocol Accepted |
04/26/2022
|
| Date Current Protocol Accepted |
08/21/2024
|
| 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 |
Objective Performance Criterion
|
| Analysis Type |
Descriptive
|
| Study Population |
Adult: >21
|
| Detailed Study Protocol Parameters |
| Study Objectives |
Prospective, adaptive design, multi-center, single arm study.
The objective of this study is to generate contemporaneous clinical data to facilitate a reasonable comparison of the performance of the FRED™ X™ device with the performance of the FRED™ device. To achieve the objective, this study will evaluate the safety and effectiveness outcomes of FRED™ X™ device in a population of patients that aligns with the indications for use of the FRED™ device. The data generated from this study will be compared to the safety and effectiveness of the FRED™ device by meeting the same performance goals (PGs) established for the
FRED™ pivotal study.
|
| Study Population |
Patients that aligns with the indications for use of the FRED™ device (See inclusion/exclusion criteria in protocol for detail)
|
| Sample Size |
The proposed enrollment target is 154 subjects at a maximum of 30 sites in the United States.
|
| Key Study Endpoints |
The primary safety endpoint is the proportion of subjects that experience either-
12 Death or major stroke within 30 days post-procedure.
13 Neurological death or major ipsilateral stroke within 12 months post-procedure.
o A major stroke is defined as a new neurological event that persists for >24 hours and results in a =4-point increase in the NIHSS score compared to baseline or compared to any subsequent lower score.
o A minor stroke is defined as a new neurological event that persists for >24 hours and results in an increase of
<4 points in the NIHSS score compared to baseline or compared to any subsequent lower score.
o A major ipsilateral stroke is defined as that occurring within the vascular distribution of the stented artery.
o Neurological death is defined as a death which has been adjudicated by the independent clinical events committee to have directly resulted from a neurologic cause.
Primary Effectiveness Endpoint:
1 The primary effectiveness endpoint is the percent of subjects
with successful aneurysm treatment as defined by complete occlusion (100%) of the target aneurysm and =50% stenosis of the parent artery at the target IA at 12 months and in whom an alternative treatment of the target IA had not been performed within 12 months post-FRED™ X™ Device placement.
An alternative treatment is defined as re-treatment of the target aneurysm with an alternative treatment modality including open repair, endovascular placement of an additional stent or treatment of in-stent stenosis observed at the 6-month or 12-month follow-up time points or at an unscheduled follow- up visit.
|
| Follow-up Visits and Length of 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).
|
| Interim or Final Data Summary |
| Interim Results |
29 adverse events
|
| Actual Number of Patients Enrolled |
29
|
| Actual Number of Sites Enrolled |
18
|
| Final Effect Findings |
N/A
|
