Post-Market Clinical Evaluation of the Gentuity High-Frequency Optical Coherence Tomography Imaging System and Vis-Rx Micro-Imaging Catheter
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 257
- 试验地点
- 3
- 主要终点
- Clinical performance
研究概览
简要总结
Post-market clinical evaluation of the Gentuity High-Frequency Optical Coherence Tomography (HF-OCT) System and the Vis-Rx Micro-Imaging Catheter for use in Percutaneous Coronary Intervention (PCI) procedures.
详细描述
Prospective, single-arm, unblinded, multi-center, post-market clinical evaluation assessing the imaging capabilities of the Gentuity HF-OCT System and the Vis-Rx Micro-Imaging Catheter for use in PCI procedures. Objectives are to evaluate the clinical and technical performance in the target patient population.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •18 years of age or older
- •Willing and able to provide written informed consent to participate
- •Transluminal interventional procedure for their coronary arteries
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 (CABG) surgery
- •Disqualified for PCI procedure
- •Currently enrolled in another study to evaluate an investigational device or medication
- •Lesion-Specific Exclusion Criteria:
- •Total occlusion
- •Coronary artery spasm
- •Large thrombus (visible under angiography)
- •Any target vessel which has undergone a bypass procedure
结局指标
主要结局
Clinical performance
时间窗: Immediately after the procedure
Operator evaluation of performance via Likert scale
Technical performance
时间窗: Up to 3 months following the procedure
Objective measurement of image clarity of the HF-OCT images by an independent core lab
次要结局
- Complete pullbacks(Up to 3 months following the procedure)