NCT07205302尚未招募不适用
Safety and Efficacy of the Flow Diverter in the Treatment of Intracranial Non-saccular Aneurysm
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 168
- 主要终点
- Complete occlusion rate of aneurysm 12 months after surgery
研究概览
简要总结
Using data obtained from the treatment of intracranial non-saccular aneurysms with flow diverter, evaluate the effecy and safety of blood flow diverter for the endovascular treatment of intracranial non-saccular aneurysms.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •Age 18 to 80 years, any gender
- •Diagnosed as a non-saccular aneurysm in the patient's intracranial region
- •Subject or guardian is able to understand the purpose of study, shows sufficient compliance with the study protocol and provides a signed informed consent form
排除标准
- •Aneurysm rupture within 30 days before enrollment;
- •Diagnosis of multiple aneurysms and requiring reoperation within 12 months
- •Conditions that are not appropriate for stent delivery and deployment judged by investigators (severe stenosis of parent artery, severe tortuosity of parent artery, stent failing to reach the lesion, stent in the target lesion of parent artery, etc.);
- •Heart, lung, liver and renal failure or other severe diseases (intracranial tumor, systemic infection, disseminated intravascular coagulation, myocardial infarction within 12 months before enrollment, history of severe psychosis, severe stenosis or occlusion of cerebral feeding artery, etc.);
- •Major surgery within 30 days before enrollment，or planned to undergo surgery within 360 days after enrollment;
- •Known allergies or contraindications to anesthetics, anticoagulants, and antiplatelet drugs;
- •Known allergy to nickel-titanium alloy metal materials;
- •Life expectancy <12 months;
- •Pregnant or breastfeeding women;
- •Subject has participated in other clinical trials within 1 month before signing informed consent;
- •Other conditions judged by the investigators as unsuitable for enrollment.
结局指标
主要结局
Complete occlusion rate of aneurysm 12 months after surgery
时间窗: 12 months after surgery
Complete occlusion is defined as no significant blood flow ,and achieves Raymond-Roy class I , which is diagnosed by cerebrovascular DSA at 6 months post-procedure.
次要结局
未报告次要终点
研究者
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