跳至主要内容
临床试验/NCT07761598
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

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

发起方
Jacobs institute
申办方类型
Other
责任方
Sponsor

研究点 (1)

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