A Retrospective, Multicenter, Controlled Clinical Trail: to Evaluate the Efficiency and Safety of Intracranial Aneurysm Assistive Software in the Preoperative Assessment
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- concordance rate
研究概览
简要总结
the goal of this clinical trail is to evaluate the efficiency and safety of intracranial aneurysm assistive software in the preoperative assessment. The trail is designed as retrospective, multicenter, controlled clinical trail. Collecting probable cases images retrospectively according to inclusion criteria and exclusion criteria strictly. Controlling bias strictly, to make sure the efficiency and safety of intracranial aneurysm assistive software is evaluated reliably and precisely. In our trail, software-assisstant planning controls against experienced-surgeon-independent planning，which aims to avoid bias effictively and eliminate non-test interferences.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •aged 18-80y, no gender limitation.
- •non-ruptured intracranial saccular aneurysm with specific intracranial CTA images; Target aneurysm has performed intravascular coiling treatment.
- •intracranial aneurysm diameter range from 3mm to 10mm.
- •the shape of aneurysm is regular without daughter sac or more than 2 lobulations.
- •Inclusion criteria of images:
- •the number of detector rows of Computed Tomography(CT) is more than 16 rows.
- •slice thickness ≤ 0.625mm, whole-brain image is considered.
- •Both plain scan sequences and enhancer sequence are required.
排除标准
- •combined with cerebral hemorrhage;
- •combined with cerevascular malformation or cerebral occupying lesion;
- •fusiform aneurysm or dissection aneurysm;
- •significant proximal stenosis of parent artery;
- •intracaverous internal carotid artery aneurysm;
- •target aneurysm has been performed flow-diverter stents treatment.
- •Exclusion criteria of images:
- •none DICOM format;
- •quality score less than 3 scores;
- •metal artifacts existance.
结局指标
主要结局
concordance rate
时间窗: accessment time point : immediately after computational coiling diameter assessment finished.
the optimal coiling diameter used in surgery is considered as "gold standard". The concordance rate is defined as computational suitable coiling diameter in test group differs gold standard less than ±1mm. concordance rate=the number of concordance matched/totle enrolled number\*100%
次要结局
- coincidence rate(accessment time point: immediately after computational coiling diameter assessment finished.)
研究者
Wang Shuo
Director of Department of Cerebrovascular Neurosurgery
Beijing Tiantan Hospital