NCT07761598尚未招募不适用
The TERUMO FRED X EARLY FEASIBILITY STUDY (FAST) STUDY.
Jacobs institute1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2026年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- A thromboembolic event in the territory supplied by the treated artery.
研究概览
简要总结
The TERUMO FRED X EARLY FEASIBILITY STUDY (FAST) is a prospective, single-arm investigation.
详细描述
The FAST study is an Early Feasibility Study (EFS), prospective, open-label, single-arm, unblinded, fifteen (n=15) patient investigation
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
- 22 Years 至 85 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has a single untreated target IA.
排除标准
- •Subject with anatomy not appropriate for endovascular treatment.
研究组 & 干预措施
Single arm study for a medical device for the FREDX device for aneurysm cerebral treatment with DAPT
Experimental
干预措施: Fred X Medical Device Intervention for Aneurysm Treatment with DAPT Therapy. (Device)
结局指标
主要结局
A thromboembolic event in the territory supplied by the treated artery.
时间窗: 12 months
A thromboembolic event in the territory supplied by the treated artery.
次要结局
未报告次要终点
研究者
研究点 (1)
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