Investigation of Clinical and Hemodynamic Factors Affecting the Outcome of Intracranial Aneurysm Embolization
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- hemodynamic factors related to aneurysm recanalization as assessed by computational blood flow simulation
研究概览
简要总结
This study was designed to collect a large series of patients with aneurysms treated endovascularly to analyze hemodynamic factors that affect aneurysm recanalization.
详细描述
With the rapid development of endovascular technique, endovascular treatment has become the first line treatment for intracranial aneurysms (IAs). Compared to microsurgical clipping, less invasive and lower morbidity have been shown after endovascular treatment. However, the aneurysms recanalization is the drawback of such modality. It has been reported that many factors, including complete initial embolization, stent assisted coiling, dense packing and flow diverter, could reduce recanalization rate. Larger size, wide neck, rupture status and intraluminal thrombosis are reported as risk factors of aneurysm recanalization. However, no analysis of hemodynamic risk factors affecting the aneurysm recanalization has been conducted in a large prospective series of patients.
Hemodynamics is reported to play an important role in aneurysm initiation, growth and rupture. Previous studies have showed that the hemodynamics is associated with outcomes of aneurysms after endovascular treatment. High wall shear stress and flow velocity are risk factors of aneurysm recanalization. However, the relationship between hemodynamics and aneurysm outcomes is still unclear. To explore the hemodynamic predictors of aneurysm recanalization is of great value for clinical practice.
Hemodynamic analysis for intracranial aneurysms recanalization after endovascular treatment (HARET) is a prospective trial designed to collect a large series of patients with aneurysms treated endovascularly to analyze hemodynamic factors that affect aneurysm recanalization.
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
- •Patients treated by endovascular approach for intracranial aneurysm(s)
- •Patients older than 18 years
- •Patients accepting to participate to the study
排除标准
- •Patients already treated by endovascular approach for an intracranial aneurysm
- •Patients having a brain arteriovenous malformation
- •Patients having a fusiform aneurysm
- •Patients having a dissecting aneurysm
- •Patients treated by parent vessel occlusion
- •Patients treated by covered stent
- •Patients lacking 3-dimensional aneurysm images or the images not satisfied the simulation
结局指标
主要结局
hemodynamic factors related to aneurysm recanalization as assessed by computational blood flow simulation
时间窗: assessed at 6 months (plus or minus 3 months) after procedure
Using computational fluid dynamic method, the parameters as wall shear stress (WSS), flow velocity, pressure could be calculated and analyzed. These will be studied as a composite indicator for recanalization assessment.
次要结局
- clinical factors related to aneurysm recanalization as recorded from medical chart(assessed at 6 months (plus or minus 3 months) after procedure)
研究者
Xinjian Yang, MD
Vice Chair of Department of Interventional Neuroradiology
Beijing Neurosurgical Institute
