Study to Evaluate Cerebral AneurysmFlow Results in Occlusion

Ki vehet részt

• Subject with unruptured, ≥5mm saccular aneurysm(s) located in the anterior intracranial circulation and suitable for an endovascular treatment with a Flow Diverter Stent
• Subject is 18 years of age or older, or of legal age to give informed consent per state or national law
• Subject is available for clinical follow-ups

Ki nem vehet részt

• Non-saccular brain aneurysm(s) (i.e. dissecting, fusiform, atherosclerotic, mycotic, bifurcational). Prior aneurysm treatment with either endovascular (stenting, coiling) or surgical (clipping) techniques
• Subject participates in a potentially confounding drug or device trial during the course of the study
• Significant or severe allergy to intra-arterial contrast medium uncontrolled by pre-procedure medications
• Severe kidney disease (Glomerular Filtration Rate < 60)
• Subject meets an exclusion criteria according to national law (e.g. age, pregnant woman, breast feeding woman)
• Endovascular treatment assisted with coils or intracranial stents
• Subjects not willing (or able) to attend post FDS insertion standard-of-care follow up clinic visits requiring DSA, head MRI or CTA imaging