N/A
N=145
Pivotal Study of the FRED Stent System in the Treatment of Intracranial Aneurysms
Intracranial Aneurysms
Bottom Line
View on ClinicalTrials.gov: NCT01801007 ↗Enrolled (actual)
145
Serious AEs
43.5%
Results posted
Oct 2020
Primary outcome: Primary: Percentage of Participants With Complete Occlusion of the Target Aneurysm and ≤50% Stenosis of the Parent Artery and an Alternative Treatment of the Target Intracranial Aneurysm (IA) Had Not Been Performed Within 12 Months — 57.0 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Flow Re-Direction Endoluminal Device (FRED) (Device)
- Age
- Adult, Older Adult · 22+ yrs
- Sex
- All
- Sponsor
- Microvention-Terumo, Inc.
- Primary completion
- Jan 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Complete Occlusion of the Target Aneurysm and ≤50% Stenosis of the Parent Artery and an Alternative Treatment of the Target Intracranial Aneurysm (IA) Had Not Been Performed Within 12 Months |
57.0 | — |
| PRIMARY Percentage of Participants Who Experience Neurological Death or Major Ipsilateral Stroke Measured by the Modified Rankin Scale (mRS) and the National Institute of Health Stroke Scale (NIHSS) |
9 | — |
| SECONDARY Percentage of Participants With Complete Occlusion of the Target Aneurysm on 12-month Angiography (Raymond-Roy 1) |
88 | — |
| SECONDARY Percentage of Participants With ≥ 50% In-Stent Stenosis (ISS) at the Target Intracranial Aneurysm (IA) at 12 Months as Assessed by Angiography at the Independent Core Laboratory |
6 | — |
| SECONDARY Percentage of Participants in Whom an Unplanned Alternative Treatment of the Target IA Had Not Been Performed Within 12 Months |
132 | — |
| SECONDARY Percentage of Participants With Clinically Acceptable (90-100%) Occlusion of the Target Aneurysm, ≤ 50% Stenosis of the Parent Artery at the Target IA, and an Unplanned Alternative Treatment of the Target IA Had Not Been Performed |
100 | — |
| SECONDARY Percentage of Participants With Unsuccessful Delivery of the FRED |
2 | — |
| SECONDARY Percentage of Participants That Had Procedure Related Serious Adverse Events With the FRED System |
40 | — |
Summary
The purpose of this study is to evaluate the safety and effectiveness of the MicroVention Flow Redirection Intraluminal Device (FRED) system when used in the treatment of wide-necked intracranial aneurysms.
Eligibility Criteria
Inclusion Criteria
- Participant whose age ≥ 22 and ≤75 years
- Participant has single target aneurysm located in the internal carotid artery
- Participant sign and date an IRB/EC approved informed consent prior initiation of any study procedures
Exclusion Criteria
- Participant who suffers from an intracranial hemorrhage in the last 30 days
- Participant who suffers from a subarachnoid hemorrhage in the last 60 days
- Participant with symptomatic extracranial mass or currently undergoing radiation therapy for tumor of the head and neck region
- Participant who is pregnant or breastfeeding
- Participant has an arteriovenous malformation (AVM) in the area of the target aneurysm
Data sourced from ClinicalTrials.gov (NCT01801007). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.