An observational study in Intracranial Aneurysm, sponsored by Microvention-Terumo, Inc.. Completed at 7 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-29.
Sponsored by Microvention-Terumo, Inc. · Observational
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.
Patients aged a minimum of 18 years with an unruptured or recanalized intracranial aneurysm in whom endovascular treatment has been determined the appropriate treatment
Patient harboring an unruptured intracranial aneurysm:
Exclusion Criteria:
Patient has another aneurysm previously treated with a stent or a flow diverter
Flow Re-Direction Endoluminal Device
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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Microvention-Terumo, Inc.