Clinical Feasibility Evaluation of the Gentuity HF-OCT Imaging System With Vis-M Micro-Imaging Catheter
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Device Safety
研究概览
简要总结
This study is a prospective, single arm, unblinded, and open-label study. The study is designed to evaluate the use of the Gentuity Neurovascular Imaging System in patients undergoing elective neurointerventional diagnostic procedures.
详细描述
Patients undergoing elective, neurointerventional procedures, or patient undergoing follow-up diagnostic procedures who meet all inclusion criteria and none of the exclusion criteria will be considered for enrollment. The study investigates the use of the Gentuity Neurovascular Imaging System as a diagnostic tool for intravascular imaging in the cerebrovasculature. The study evaluates the incidence and severity of device-related adverse events, clinical usability performance and technical performance of imaging quality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 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
- •Patients who are electively scheduled for either a follow-up cerebral angiogram or a diagnostic angiogram and may be candidates for a neuroendovascular procedure
- •Patients that present with a Modified Rankin Score (mRS) ≤3
- •Patients 18 years of age or older
- •Patients willing and able to provide written informed consent to participate in evaluation
排除标准
- •Patients with serious concurrent medical conditions including bacteremia or sepsis, acute renal failure at the time of the procedure, and major coagulation system abnormalities that in the opinion of the investigator could significantly increase risk
- •Patient has a known hypersensitivity to contrast media
- •Patients undergoing an urgent or emergent neurointerventional procedure
- •Patients that present with a Modified Rankin Score (mRS) ≥4
- •Patients that present with an unresolved spontaneous subarachnoid hemorrhage and/or intracranial hemorrhage
- •Participation in another clinical trial of an investigational drug or device
- •Patient has existing Flow Re-Direction Endoluminal Device (FRED®) System
结局指标
主要结局
Device Safety
时间窗: 7 days
Incidence and severity of device-related adverse events.
次要结局
- Clinical performance(1 day)
- Technical performance(1 day)