NCT06972953进行中（未招募）不适用
NEUROvascular NAVgation With Remotely Controlled Deflectable Guidewire, Study I (NeuroNAV Study I)
Artiria Medical2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2025年6月16日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 30
- 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 confirm the safe and successful use of the SmartGUIDE guidewire, when used in neuro interventions. The performance of the SmartGUIDE guidewire in terms of safe and successful navigation within the neurovasculature will be compared to standard of care guidewire on the market.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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 the 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
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 target vessel without need for shaping by hand, removal or exchange.
次要结局
- Usability(During index procedure)
- Procedural times(During index procedure)
- Intra-procedural device deficiencies(During index procedure)
- Intra-procedural adverse events(During index procedure and up to 48 hours post procedure)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
NEUROvascular NAVigation With Remotely Controlled Deflectable Guidewire, Study II (NeuroNAV Study II)NCT06972966Artiria Medical28
终止
不适用
Real-time Deflectable Guidewire in Neuro-interventions StudyUnruptured Cerebral AneurysmNCT05564325Artiria Medical5
已完成
不适用
Neuronavigation rTMS to Improve Depressive Episodes of Bipolar Disorder in AdolescentBipolar DisorderNCT05929183First Affiliated Hospital of Zhejiang University40
尚未招募
不适用
Single Arm, Prospective, Open-label, Multi-center Clinical Investigation for the Demax Guide WirePeripheral Vascular DiseasesCoronary Artery DiseaseNCT06735846DemaxGroup100
已完成
不适用
Coil Positioning in Navigated Transcranial Magnetic Stimulation Feasibility in Depression Patients TrialDepressive Disorder, MajorNCT03795051Magstim30