Multicenter observational cohort study to evaluateCerebral AneurysmFlow Results in Occlusion (CARO) - CARO

Philips0 个研究点目标入组 0 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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

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

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