Vis-Rx Prime Micro-Imaging Catheter Clinical Evaluation Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 5
- 主要终点
- Clinical performance
研究概览
简要总结
To study the performance of the Gentuity® HF-OCT (High Frequency Optical Coherence Tomography) Imaging System and Vis-Rx Prime® Micro-Imaging Catheter when used to obtain images of coronary arteries in patients who are undergoing cardiac catheterization and are candidates for interventional procedures. The study will evaluate ease of catheter use by physicians using the catheters, image quality and overall performance. The patient's involvement in the study ends when the cardiac catheterization/interventional procedure is completed.
详细描述
This is a single arm, unblinded, multi-center, clinical evaluation that will be performed at 3 to 5 investigational sites in the United States with subjects who undergo HF-OCT imaging as part of their cardiac catheterization procedure. This study will evaluate a range of device operators (interventional cardiologists) as well as patients and vessels consistent with the product labeling. The operator evaluation will be determined post use of the device using a Likert Grading Scale. Clear Image Length of the acquired HF-OCT image will be measured by an independent core lab. Safety will be monitored through the interventional procedure and Adverse Events that are potentially related to either the device or the procedure will be recorded, evaluated and analyzed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 18 years of age or older
- •Patients willing and able to provide written informed consent to participate in evaluation
- •Patients who are candidates for transluminal interventional procedures for their coronary arteries (also known as PCI)
排除标准
- •Bacteremia or sepsis
- •Major coagulation system abnormalities
- •Severe hemodynamic instability or shock
- •Acute renal failure
- •Disqualified for Coronary Artery Bypass Graft surgery
- •Disqualified for Percutaneous Coronary Intervention
- •Patients currently enrolled in another study to evaluate an investigational device or medication
- •Any target vessel which has undergone a bypass procedure
- •The lesion-specific exclusion criteria assessed from angiography are:
- •Total occlusion
- •Coronary artery spasm
- •Large thrombus (as visible under angiography)
结局指标
主要结局
Clinical performance
时间窗: During percutaneous interventional procedure
Clinical performance of the Gentuity HF-OCT Imaging System with the Vis-Rx Prime Micro-Imaging Catheter in a real-world setting as determined by the clinical operator using a Likert Grading Scale (1-5 scale; 1=unacceptable, 5= excellent)
Technical Performance
时间窗: During percutaneous interventional procedure
Clear Image Length of the acquired HF-OCT image
Technical Performance
时间窗: During percutaneous interventional procedure, up to 2 hours
Clear Image Length of the acquired HF-OCT image during each pullback during a percutaneous coronary intervention procedure
次要结局
- Clinical Performance Endpoint(During percutaneous interventional procedure, up to 2 hours.)