Pivotal Study Of The FRED Stent System In The Treatment Of Intracranial Aneurysms
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Rochester, Minnesota: 14-001982
NCT ID: NCT01801007
Sponsor Protocol Number: CL12001
About this study
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.
Participation eligibility
Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
- Subject whose age ≥ 22 and ≤ 75 years
- Subject has single target aneurysm located in the internal carotid artery
- Subject fulfills study requirements and his/her legally authorized representative provides a signed informed consent form
Exclusion Criteria:
- Subject who suffers from an intracranial hemorrhage in the last 30 days
- Subject who suffers from a subarachnoid hemorrhage in the last 60 days
- Subject with symptomatic extracranial mass or currently undergoing radiation therapy for tumor of the head and nexk region
- Subject who is pregnant or breastfeeding
- Subject has an arteriovenous malformation (AVM)in the area of the target aneurysm
Participating Mayo Clinic locations
Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.
| Mayo Clinic Location |
Status |
|
Rochester, Minn.
Mayo Clinic principal investigator David Kallmes, M.D. |
Closed for enrollment |
|
More information
Publications
Publications are currently not available