N/A
Completed N=145
Pivotal Study of the FRED Stent System in the Treatment of Intracranial Aneurysms
Source: ClinicalTrials.gov NCT01801007 ↗Enrolled (actual)
145
Serious AEs
43.5%
Results posted
Oct 2020
Primary outcomePrimary: 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
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.
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 | — |
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. Informational only — not medical advice.