NCT04617899Unknown不适用
The Study to Evaluate the Performance and Safety of the Novasight Hybrid System Using Objective Performance Criteria
CardioNavi MedTech (Wuhan) Co., Ltd.4 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2021年3月17日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- Clear image length measured by Core lab
研究概览
简要总结
This prospective, multicenter, single-arm study aims to evaluate the safety, operability and practicability of the novel hybrid intravascular imaging system/catheter during the percutaneous transluminal coronary intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject must be at least 18 years of age and less than 85 years of age.
- •Subject must be informed and sign a written consent
- •Subject must have evidence of myocardial ischemia, unstable angina or acute myocardial infarction suitable for PCI.
排除标准
- •Women who are pregnant or cannot eliminate the possibility to be pregnant.
- •Estimated creatinine clearance <30 ml/min/1.73 m2 using Cockcroft equation.
- •LVEF(Left ventricular ejection fraction) < 35% by the most recent imaging test within 7 days prior to procedure.
- •Unstable ventricular arrhythmias.
- •High bleeding risk, active peptic ulcers or cerebrovascular accident or transient ischemic attack within the past 6 months.
- •Known contraindication to anticoagulants and antiplatelets therapy.
- •Known hypersensitivity to aspirin, clopidogrel, heparin, iodinated contrast, ticagrelor, bivalirudin, metal materials in stent.
- •Any intervention for not target vessel within 48 hours after the study procedure.
- •Any conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation.
- •Angiographic exclusion criteria:
- •The reference diameter of target vessel is less than 2.5 mm.
- •The target lesion involves myocardial bridge.
- •The target lesion is in the left main coronary artery or the damage is observed in the ostium.
- •Severe calcification in the target vessel.
- •Severe tortuosity in the target vessel.
- •Multiple contiguous stent implantation in the target vessel.
- •Subject has coronary artery spasm.
- •In-stent restenosis.
- •Any study lesion characteristic that, in the investigator's opinion, is not available for intravascular imaging.
结局指标
主要结局
Clear image length measured by Core lab
时间窗: During the procedure
The clear image length is transformed from the clear image frame, and the ratio of the clear image can be calculated by Clear image length / Full image length \* 100%
次要结局
- Catheter-related major adverse events(Periprocedure)
- Clear stent length measured by Core lab(During the procedure)
- Device Success(During the procedure)
- Technical Success(During the procedure)
- Image quality evaluated by operator(During the procedure)
- System reliability evaluated by operator(During the procedure)
- Catheter operability evaluated by operator(During the procedure)
研究者
研究点 (4)
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