NCT05564325终止不适用
Real-time Deflectable Guidewire in Neuro-interventions Study
Artiria Medical2 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2023年4月19日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Performance
研究概览
简要总结
The aim of the study is to assess the safe and successful use of the SmartGUIDE guidewire in neuro interventions and to compare to standard of care guidewires on the market.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •>18 years of age
- •Informed consent signed by patient
- •Confirmed cerebral unruptured aneurysm treatable via transcatheter approach
排除标准
- •Pregnancy or lactation
- •Known disorder of vascular fragility with propensity to vascular injury (e.g., Ehlers-Danlos syndrome)
- •Known prior vascular stenosis or dissection or injury to vessels intended to be catheterized during study procedures
- •Acute phase myocardial infarction or uncontrolled cardiac arrhythmia
- •Uncontrolled serum electrolyte imbalance
- •Bleeding disorder which limits the use of antiplatelet and/or anticoagulant therapy
- •Known contraindication to intravascular contrast material that cannot be adequately controlled with pre-medication
- •Known hypersensitivity to Nickel
- •Subjects currently enrolled in another investigational device or drug study that clinically interferes with the current study endpoints
研究组 & 干预措施
SmartGUIDE (deflectable guidewire)
Experimental
干预措施: SmartGUIDE (deflectable guidewire) (Device)
结局指标
主要结局
Performance
时间窗: During index procedure
Intra-procedural technical success defined as successful navigation of device to the vascular target vessel without need for shaping, removal or exchange.
次要结局
- Procedural times(During index procedure)
- Safety - intra- and postprocedural(During index procedure and up to 48 hours post procedure)
- Device Deficiencies(During index procedure)
- Usability(During index procedure)
研究者
研究点 (2)
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