Pivotal Study of the MicroVention Flow Re-Direction Endoluminal Device (FRED) Stent System in the Treatment of Intracranial Aneurysms
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 145
- Locations
- 47
- Primary Endpoint
- 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
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 22 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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
Time Frame: 12 months
The primary effectiveness endpoint has three components: 1) complete occlusion of the target aneurysm assessed by a core laboratory utilizing the Raymond-Roy Scale 2) ≤ 50% stenosis of the parent artery at the target (IA) using the Warfarin-Aspirin Symptomatic Intracranial Disease(WASID) criterion which is defined as greater than 50% luminal loss, 3) alternative treatment of the target IA 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. The Raymond-Roy Occlusion Classification has 3 responses, where Grade I is complete occlusion, no flow of contrast seen in the sac, Grade II is partial occlusion, some flow in the neck or sac, and Grade III is incomplete occlusion, apparent flow into the sac. Grade 1 indicates the best outcome.
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)
Time Frame: 12 months
A major stroke is defined as a new neurological event that persists for \> 24 hours and results in a ≥ 4 points increase in the NIHSS score compared to baseline or compared to any subsequent lower score. A major ipsilateral stroke is defined as that occurring within the vascular distribution of the stented artery. Neurologic death is defined as a death which has been adjudicated by the independent clinical events committee to have directly resulted from a neurologic cause.The NIHSS score ranges from 0 (no stroke symptoms) to 42 (severe stroke). mRS is 6 point assessment scale used to assess disability in patients who have suffered a stroke and is compared over time to check for recovery and degree of continued disability. The mRS score ranges from 0 (no disability) to 6 (death).
Secondary Outcomes
- 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(12 months)
- 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(12 months)
- Percentage of Participants in Whom an Unplanned Alternative Treatment of the Target IA Had Not Been Performed Within 12 Months(12 months)
- Percentage of Participants With Complete Occlusion of the Target Aneurysm on 12-month Angiography (Raymond-Roy 1)(12 months)
- Percentage of Participants With Unsuccessful Delivery of the FRED(Index Procedure)
- Percentage of Participants That Had Procedure Related Serious Adverse Events With the FRED System(12 months)