Multicenter Observational Cohort Study to Evaluate Cerebral AneurysmFlow Results in Occlusion
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 132
- 试验地点
- 4
- 主要终点
- Prognostic Value of the MAFA (Mean Aneurysm Flow Amplitude) Ratio With Respect to Full Aneurysm Occlusion Within 12 Months
研究概览
简要总结
AneurysmFlow R1.0 is an approved (i.e. CE labeled, 510k, Health Canada), software tool intended to provide relevant information on the blood flow in a cerebral aneurysm and its parent artery based on angiography. It calculates the Mean Aneurysm Flow Amplitude (MAFA) ratio to measure the volumetric flow rate quotient before and after Flow Diverter Stent (FDS) implantation in the region of interest.
The current study is a prospective, single arm, observational, multicenter cohort study to assess the prognostic value of the MAFA ratio for predicting full aneurysm occlusion 12 months after flow diverter placement.
详细描述
AneurysmFlow R1.0 is an approved (CE labeled, cleared in US, Canada and Argentina), software tool intended to provide relevant information on the blood flow in a cerebral aneurysm and its parent artery based on angiography. It provides color coded and vector field representation of a digital subtraction angiography (DSA). It can quantify blood flow rates in the artery based on DSA and 3-D Rotational Angiogram (3DRA) data. It can visualize blood flow patterns in an aneurysm based on DSA data. Specifically, it calculates the Mean Aneurysm Flow Amplitude (MAFA) ratio to measure the volumetric flow rate quotient before and after Flow Diverter Stent (FDS) implantation in the region of interest. It is manufactured by Philips Medical Systems bv., a Philips Healthcare company.
120 subjects with unruptured, >5mm saccular aneurysm(s) located in the anterior intracranial circulation and suitable for an endovascular treatment with a Flow Diverter Stent will be enrolled in the study. The enrollment period is expected to last for 1 year.
Physician investigators participating in this study are expected to follow their normal clinical practice in enrolling, treating and following patients with intracranial aneurysms that are amenable to treatment with flow diverter stents. No additional procedures are required of patients in order to participate in this observational study.
Pre-Screening
Patients presenting with intracranial saccular aneurysm(s) will be evaluated by the neuro interventional team, in accordance with institutional practice, to establish an appropriate treatment plan based on the patient's medical condition and available diagnostic screening procedures prior to recruitment in the study. More than one aneurysm in a single patient may be treated, but only one target aneurysm treated with an FDS device will be considered as part of this study. If treatment of the aneurysm with the FDS is deemed appropriate, the institution's guidelines regarding their ethics committee and informed consent process will be followed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
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 (Glomerular Filtration Rate < 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, breast feeding woman).
结局指标
主要结局
Prognostic Value of the MAFA (Mean Aneurysm Flow Amplitude) Ratio With Respect to Full Aneurysm Occlusion Within 12 Months
时间窗: 12 months
To assess the prognostic value (i.e. c-statistic including confidence intervals) of the MAFA ratio with respect to full aneurysm occlusion (i.e. using the Raymond-Roy Occlusion Classification I on standard-of-care head imaging) 12 months after Flow Diverter Stent placement. The objective was evaluated using logistic regression analysis to evaluate the univariate predictive association between the index test (i.e., the MAFA ratio) and complete aneurysm occlusion (i.e., complete occlusion yes/no) at 12 months. The primary endpoint was presented using a Receiver Operating Characteristic (ROC) curve including the c-statistic (also known as the Area Under the Curve (AUC) of the ROC curve) and confidence intervals.
次要结局
- Prognostic Value of the MAFA Ratio With Respect to Full Aneurysm Occlusion Within 6 Months(6 months)
- Optimal MAFA Threshold(12 months)
- Serious Adverse Events(12 months)