Interest of Pre-operative Use of 3D Printing for Endovascular Treatment of Unruptured Intracranial Aneurysms With Intrasaccular Flow Disruptor
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Proportion of patients with successful procedure
研究概览
简要总结
This is a preliminary randomised controlled trial comparing the use of pre-operative 3D models to select an intrasaccular flow disruptor for endovascular aneurysm cure.
详细描述
Patients will be randomised 3:1 either in the intervention or control group. Intervention consists of using the pre-operative Digital Subtraction Angiography (DSA) to create a 3D plastic model. This model is used to test different sizes of device. At the end of this pre-operative test a single device is recommended for the real procedure. The control group will use the current method for size selection (measurement of mean width and minimum height) on DSA.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Intracranial aneurysm, suitable for a treatment by Woven Endobridge (WEB) device after multidisciplinary team decision
- •Consent form signed
- •The patient benefits from health insurance
排除标准
- •Legal incapacity
- •Women at risk of pregnancy
研究组 & 干预措施
With 3D anatomical model
Surgery prepared using 3D anatomical model of the aneurysm
干预措施: 3D anatomical model of aneurysm (Procedure)
Without 3D anatomical model
Surgery prepared without 3D anatomical model of the aneurysm (routine care)
结局指标
主要结局
Proportion of patients with successful procedure
时间窗: Day 0
Proportion of patients for which flow disruption succeeded at first intent, without any change of size required for WEB disruptor
次要结局
未报告次要终点