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

Philips1 个研究点分布在 1 个国家目标入组 120 人开始时间: 2019年1月5日最近更新: 2019年4月18日

试验速览

阶段: 不适用
状态: 尚未招募
发起方: Philips
入组人数: 120
试验地点: 1
主要终点: months after flow diverter placement

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a prospectively planned, single arm, observational, multicenter cohort study to assess the prognostic value of the MAFA ratio using AneurysmFlow (i.e. an approved software tool from Philips intended to provide relevant information on the blood flow in a cerebral aneurysm and its parent artery based on angiography 2D flow measurement) for predicting full aneurysm occlusion 12 months after flow diverter placement.

研究设计

研究类型: Observational

入排标准

年龄范围: 18.00 Year(s) 至 99.00 Year(s)（—）
性别: Male

入选标准

•Subject with unruptured, 5rnm 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.

排除标准

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

结局指标

主要结局

months after flow diverter placement

时间窗: 12 months after flow diverter placement

Full aneurysm occlusion 12

时间窗: 12 months after flow diverter placement

次要结局

Full aneurysm occlusion 6(months after flow diverter placement)

研究者

发起方

Philips

申办方类型

Other [Medical Device Company]

研究点 (1)

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