NCT07376590招募中不适用
Multicenter Study to Evaluate the Effectiveness and Safety of Flow-Diverting Stents for Distal Intracranial Aneurysms
First Affiliated Hospital of Zhejiang University1 个研究点 分布在 1 个国家目标入组 164 人开始时间: 2026年1月15日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 164
- 试验地点
- 1
- 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 distal intracranial aneurysms with flow diverter, evaluate the effecy and safety of blood flow diverter for the endovascular treatment of distal intracranial aneurysms.
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 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，Subjects who have accepted treatment with flow-diverting for distal intracranial aneurysms
- •Diagnosed with an intracranial aneurysm by CTA, MRA, or DSA, with the following features: a wide neck (≥4mm), or a dome-to-neck ratio <2, saccular, fusiform aneurysms, recurrent saccular aneurysms, and dissecting aneurysms. Locations include: the Circle of Willis and it's distal branches such as the middle cerebral artery (MCA) M1-M3 segments, anterior cerebral artery (ACA) A1-A3 segments, posterior cerebral artery (PCA) P1-P2 segments, etc. (intracranial aneurysms of the Circle of Willis and it's distal vessels).
- •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
- •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.)
- •mRS score ≥3
- •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.)
- •Platelet count <60×10^9/L, known platelet dysfunction, or international normalized ratio (INR) >1.5
- •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
- •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
次要结局
未报告次要终点
研究者
研究点 (1)
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