A Prospective, Single Center, Non-randomized, Single Arm, Open Label, Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Cardiovascular Adverse Events (Primary Safety)
研究概览
简要总结
This is an open label, single-center, prospective, pivotal study in which the investigational device, NovaCross™ micro-catheter, will be tested in up to 15 patients scheduled to undergo CTO-PCI using an anterograde approach.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult aged 25-80
- •Patient understands and has signed the study informed consent form.
- •Patient is a suitable candidate for non-emergent, coronary angioplasty
- •Patient has an angiographic documented Chronic Total Occlusion (i.e. >3 months occlusion duration either by documentation or PI assessment Investigator) showing distal TIMI flow
- •Coronary angiography of CTO lesion reveals satisfactory distal vessel visualization
- •CTO lesion is located in a coronary vessel with a reference diameter of at least 2 millimeters.
- •CTO lesion is suitable for antegrade approach.
- •Left ventricle ejection fraction > 25%
- •Body Mass Index (BMI) < 40
排除标准
- •Patient unable to give informed consent.
- •Patient is participating in another study with any investigational drug or device.
- •Patient is known or suspected not to tolerate the contrast agent.
- •Aorto-ostial CTO location (Ostial bifurcation origins may be considered), SVG CTO.
- •Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel and Prasugrel and Ticagrelor).
- •Appearance of a fresh thrombus or intraluminal filling defects.
- •Recent major cerebrovascular event (stroke or TIA within 30 days)
- •Significant anemia (hemoglobin < 8.0 mg / dl)
- •Unstable angina requiring emergent percutaneous trans-luminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG)
- •Recent myocardial infarction (MI) (within the past two weeks)
- •Unwillingness or inability to comply with any protocol requirements
- •Pregnancy or nursing
结局指标
主要结局
Cardiovascular Adverse Events (Primary Safety)
时间窗: 30 days
Accumulative incidence of Major Adverse Cardiovascular Events (MACE), defined as the composite of death, myocardial infarction (MI), or urgent revascularization (target vessel revascularization (TVR) or urgent coronary artery bypass surgery (CABG)).
Technical Success (Primary Efficacy)
时间窗: 1 day
Intra-procedural technical success, defined as the ability of the NovaCross™ microcatheter to successfully facilitate placement of a guidewire beyond a native coronary chronic total occlusion in the true vessel lumen
次要结局
- Crossability(1 day)
- Procedual Visualization(1 day)
- Operator Ease of Use(1 day)
- Procedural Success(1 day)
- Assistance in Guidewire Penetration(1 day)
- Device Related Perforation Rate(1 day)