NCT07022249尚未招募不适用
Efficacy and Safety of a Novel Intrasaccular Embolization Device for the Treatment of Intracranial Aneurysms : a Prospective, Multicenter, Single-arm Trial
Ton-Bridge Medical Tech. Co., Ltd0 个研究点目标入组 150 人开始时间: 2025年6月1日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 主要终点
- Percentage of Subjects With Complete Aneurysm Occlusion Without Retreatment, Recurrent Subarachnoid Hemorrhage, Without Significant Parent Artery Stenosis (>50% Stenosis) at One Year After Treatment.
研究概览
简要总结
The study is a prospective, multicenter single-arm cohort. The purpose of this study is to evaluate efficacy and safety of a novel intrasaccular embolization device for the treatment of intracranial aneurysms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient must be 18-75 years of age at the time of screening.
- •Patient must have a single ruptured or unruptured IA requiring treatment.
- •Patient was able to comply with all aspects of the screening, evaluation, treatment, and the post-procedure follow-up schedule, signed and dated an written informed consent prior to initiation of any study procedures.
排除标准
- •Patient had an IA with characteristics unsuitable for endovascular treatment.
- •Patient had vessel characteristics, tortuosity or morphology which precluded safe access and support during treatment with study device.
- •Patient had vascular disease or other vascular anomaly that precluded the necessary access to the aneurysm for use of the study device.
- •Patient had vasculitis, an intracranial tumor (except benign tumors that do not require treatment) or any other intracranial vascular malformations on presentation.
- •Patient was taking anticoagulants or had a known blood dyscrasia, coagulopathy, or hemoglobinopathy.
- •Patient was pregnant.
结局指标
主要结局
Percentage of Subjects With Complete Aneurysm Occlusion Without Retreatment, Recurrent Subarachnoid Hemorrhage, Without Significant Parent Artery Stenosis (>50% Stenosis) at One Year After Treatment.
时间窗: 12 months
The Primary Safety Endpoint Included Any Death or Major Stroke in the First 30 Days and Neurologic Death or Ipsilateral Major Stroke Between Day 31 and Day 365.
时间窗: 12 months
次要结局
未报告次要终点
研究者
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