Aneurysm Packing With the Expandable TrelliX Coil System - A Prospective Safety Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Safety - Serious adverse events
研究概览
简要总结
APEX-FIH is a first-in-human, open-label prospective multicenter study of the TrelliX Embolic Coil System for use in embolization of the medium to large, ruptured or unruptured cerebral 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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject age ≥18 and ≤80 years with a diagnosis of a ruptured or unruptured intracranial aneurysm judged suitable for selective endovascular treatment by coil occlusion during single procedure
- •Aneurysm size [largest measurement from the cross sectional images to determine overall aneurysm size, not just the lumen) ≥5 mm and ≤16mm
- •If ruptured aneurysm: either WFNS grade 1 or 2, or Hunt and Hess 1 or 2
- •If unruptured aneurysm: Subject grade Modified Rankin Scale mRS 0 - 2
- •Investigator plans to use ≥70% in volume TrelliX coils to fill target aneurysm
排除标准
- •Prior treatment (surgical or endovascular) of the target aneurysm
- •Planned treatment of multiple aneurysms in index procedure
- •Planned use of other modified coils (Matrix, HydroCoil or fibered coils)
- •Planned use of liquid embolic material
- •Life expectancy less than 12 months
- •Presence of arteriovenous malformation
- •Fusiform, mycotic, traumatic, or tumoral aneurysms
- •Intended or planned aneurysm treatment by parent vessel occlusion
- •Clipping or endovascular treatment of another intracranial aneurysm performed within 30 days before or planned within 30 days following the index procedure
研究组 & 干预措施
TrelliX Embolic Coil System
干预措施: TrelliX Embolic Coil System (Device)
结局指标
主要结局
Safety - Serious adverse events
时间窗: 30 days
Rate of freedom from incidence of serious adverse events related to the study
Efficacy - Angiographic occlusion
时间窗: 6 months and 12 months
Rate of angiographic occlusion based on Raymond-Ray grading scale \[1 No filling of aneurysm neck or dome; 2 Residual filling of aneurysm neck, not dome; 3 Residual filling of aneurysm neck and dome (worst outcome)\]
Efficacy - Angiographic occlusion
时间窗: Immediate
Rate of angiographic occlusion based on Raymond-Ray grading scale \[1 No filling of aneurysm neck or dome; 2 Residual filling of aneurysm neck, not dome; 3 Residual filling of aneurysm neck and dome (worst outcome)\]
次要结局
未报告次要终点