UK Study:
Safety and Efficacy Analysis of FRED™/FRED™Jr Embolic Device in Aneurysm Treatment
FRED™ Flow Diverter
"The FRED™ and FRED™ Jr devices are safe and efficacious in the treatment of intracranial aneurysms."
- Patients
61
- Country
UK
- Clinical Centers
7
- Design
Single arm prospective
- Scope
Patients ≥18 y.o. presenting with an unruptured or recanalized IC aneurysm, from anterior circulation, requiring endovascular treatment, mRS≤2, eligible to be treated with FRED™/FRED™ Jr in UK centers.
- Purpose
To demonstrate the use of the FRED™/FRED™ Jr Embolic device in intracranial AN treatment.
To assess the safety and effectiveness when assessed at 1, 6 and 12 months post procedure.
Endpoints
Efficacy:
Complete aneurysm occlusion without stenosis (>50%) of the parent vessel at 6 months, evaluated by Corelab
Safety:
Morbidity (mRS>2) rate at 6 months
Mortality rate at 6 months
Efficacy results
At 6 months:
Primary endpoint: Complete occlusion without associated stenosis of parent artery (>50%): 63.3%
At 12 months:
Adequate occlusion: 86.7%
Safety results
At 6 months and 12 months (FAS population):
Morbidity: 0%
Mortality: 0%
LINK TO STUDY PAGE: Clinical Trials.gov ID NCT03423290
Please refer to Instruction for Use (IFU) in the specific market/country that you are looking into:
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