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 performed as per standard of care. The purpose of this study is to demonstrate that use of the FRED/ FRED Jr/ FRED X Embolic device in intracranial aneurysm treatment is safe and effective when assessed at 6, 12 months and yearly up to 5 years post procedure. 150 patients will be enrolled over an 15-month recruitment period. All patients will be followed for 5 years.
Study Type
OBSERVATIONAL
Enrollment
156
Subjects aged ≥ 18 requiring treatment for an unruptured or recanalized intracranial aneurysm
Universitätsklinikum Erlangen
Erlangen, Germany
Rate of complete aneurysm occlusion without associated stenosis of the parent artery (> 50%)
Complete occlusion (Raymond Scale grade I) without stenosis of the parent artery. Raymond scale definition: Grade I= complete occlusion of aneurysm, Grade II= Residual neck, Grade III= Residual aneurysm
Time frame: 12 months
Morbidity Rate
Patients with mRS\>2
Time frame: 6 months
Mortality Rate
Deaths within 6 months after treatment
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.