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 established for the FRED pivotal study.
FRED X PAS
MicroVention, Inc. Flow Re-Direction Endoluminal Device X (FRED X) Post-Approval Study
Brain aneurysm
All genders
22-75
Recruiting now
Overview
Principal Investigator: Dr. Adel Malek
Contact Us
Study details
Inclusion Criteria
- 1. Patient has single target aneurysm in the internal carotid artery from petrous segment to the terminus of the internal carotid artery
- 2. The parent artery diameter must be 2.0-5.0mm distal and/or proximal to the target intracranial aneurysm
- 3.modifided Rankin Scale (mRS) less than or equal to 2
Exclusion Criteria
- 1. Patient who suffers from a subarachnoid hemorrhage in the last 60 days or intracranial hemorrhage in the last 30 days
- 2. Patient with symptomatic extracranial or intracranial stenosis of the parent artery (greater than 50%) proximal tot he target aneurysm.
Study Requirements
This study follows the standard of care treatment of intracranial aneuyrsm. There will be no additional visits required for this study. After the procedure, there will be follow up visits at 1, 6, 12 months and 2-5 years.