A prospective, multicenter, observational evaluation of the safety and efficacy of the FRED® device in the treatment of intracranial aneurysms
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 device in intracranial aneurysm treatment is safe and effective when assessed at 1, 6 and 12 month post procedure. 100 patients will be enrolled over an 18-month recruitment period. All patients will be followed for 12 months.
Study Type
OBSERVATIONAL
Enrollment
61
Flow Re-Direction Endoluminal Device
University Hospital Birmingham
Birmingham, United Kingdom
Brighton & Sussex Universitys Hospitals
Brighton, United Kingdom
Western General Hospital - NHS Lothian
Edinburgh, United Kingdom
The Walton Centre NHS Foundation Trust
Liverpool, United Kingdom
Complete aneurysm occlusion without ˃ 50% parent artery stenosis
Evaluated by Corelab
Time frame: 6 months
Morbidity rate
patients with mRS\>2
Time frame: 6 months
Mortality rate
patients with mRS=6
Time frame: 6 months
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Imperial College Healthcare NHS Trust
London, United Kingdom
The Newcastle upon Tyne Hospitals NHS Foundation Trust
Newcastle upon Tyne, United Kingdom
University Hospitals of North Midlands NHS Trust
Stoke-on-Trent, United Kingdom