Status:
COMPLETED
Safety and Efficacy Analysis of FRED™/FRED™Jr Embolic Device in Aneurysm Treatment
Lead Sponsor:
Microvention-Terumo, Inc.
Collaborating Sponsors:
Clinact
Conditions:
Intracranial Aneurysm
Eligibility:
All Genders
18+ years
Brief Summary
A prospective, multicenter, observational evaluation of the safety and efficacy of the FRED® device in the treatment of intracranial aneurysms
Detailed Description
This is a multi-center observational study. Treatment and follow-up visits will be done as per standard of care. The purpose of this study is to demonstrate that use of the FRED/FRED Jr Embolic devic...
Eligibility Criteria
Inclusion
- Patient older than 18 years old
- Patient harboring an unruptured intracranial aneurysm:
- for which endovascular treatment is indicated
- for which use of FRED or FRED Jr has been deemed appropriate
- being the only one to require treatment over the period of the study
- and optionally previously treated by surgery (clipping) or with an intrasaccular device: aneurysm recanalized
- Patient with a modified Rankin Scale (mRS) ≤ 2
- Patient or patient's legally authorized representative has received information about data collection and has signed and dated an Informed Consent Form
Exclusion
- Patient has suffered an ICH within the 30 days prior to the procedure.
- The aneurysm to be treated is associated with an cAVM
- The aneurysm to be treated is a dissecting or blister-like aneurysm
- The aneurysm to be treated or any other aneurysm is in the posterior circulation
- The aneurysm to be treated has a stenosis of its parent artery
- Patient has another aneurysm previously treated with a stent or a flow diverter
- on the same parent vessel at any time (except in the case of the proximal carotid if the treatment occurred more than 3 months prior to the procedure)
- on a different parent vessel, less than 3 months prior to the procedure
- Patient has another aneurysm requiring treatment within the study period
- Patient with a known allergy to antiplatelet, to heparin, to contrast products or nickel titanium
- Patient with a contra-indication to antiplatelet or heparin
- Pregnancy or child breastfeeding
- Patient unable or unlikely to complete required follow up
- Patient has severe or fatal comorbidity or a life expectancy of less than 1 year
- Treatment with a flow diverter other than FRED/FRED Jr or in addition to FRED/FRED Jr is planned.
Key Trial Info
Start Date :
November 23 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 26 2022
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT03423290
Start Date
November 23 2017
End Date
January 26 2022
Last Update
April 29 2022
Active Locations (7)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital Birmingham
Birmingham, United Kingdom, B15 2TH
2
Brighton & Sussex Universitys Hospitals
Brighton, United Kingdom, BN2 5BE
3
Western General Hospital - NHS Lothian
Edinburgh, United Kingdom, EH4 2XU
4
The Walton Centre NHS Foundation Trust
Liverpool, United Kingdom, L97 LJ