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临床试验/NCT02812108
NCT02812108已完成不适用

Investigation of Clinical and Hemodynamic Factors Affecting the Outcome of Intracranial Aneurysm Embolization

Beijing Neurosurgical Institute1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年8月最近更新:
适应症

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xinjian Yang, MD

Vice Chair of Department of Interventional Neuroradiology

Beijing Neurosurgical Institute

研究点 (1)

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