A Prospective, Multi-Center, Non-randomized, Single Arm, Open Label, Pivotal 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
- 发起方
- 入组人数
- 60
- 试验地点
- 5
- 主要终点
- Primary Safety Measure - Rate of in-hospital MACE events
研究概览
简要总结
A Prospective, Multi-Center, Non-randomized, Single arm, Open label, Supplemental Study to Evaluate the Safety and Effectiveness of the NovaCross™ Micro-catheter in Facilitating Crossing Chronic Total Occlusion (CTO) Coronary Lesions
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 has an angiographic documented Chronic Total Occlusion (i.e. >3 months occlusion duration) showing distal TIMI flow 0, with a reference diameter of at least 2 millimeters.
- •Left ventricle ejection fraction > 25%
排除标准
- •Patient unable to give informed consent.
- •Elevated CK-MB or troponin at baseline
- •Patient is known or suspected not to tolerate the contrast agent
- •Chronic Total Occlusion is located in aorto-ostial location, SVG CTO, in-stent occlusion
- •Appearance of a fresh thrombus or intraluminal filling defects
- •Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel and Prasugrel and Ticagrelor)
- •Cardiac intervention within 4 weeks of the procedure
- •Severe renal insufficiency with eGFR<30 ml/min/1.72 m2
- •Congestive heart failure [New York Heart Association (NYHA) Class III\IV] CSA Class IV
- •Life expectancy < 2 years due to other illnesses
- •Acute or unstable medical disorder/disease that may cause a risk to patient, including:
- •i. Recent myocardial infarction (MI) (within the past two weeks) ii. Significant anemia (e.g. hemoglobin < 8.0 mg / dl) iii. Recent major cerebrovascular event (history of stroke or TIA within 1 month) iv. Severe uncontrolled systemic hypertension (e.g., >180/100 mmHg) v. Unstable angina requiring emergent percutaneous trans-luminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG)
研究组 & 干预措施
NovaCross
the NovaCross is a guidewire positioning and support micro-catheter for improving chronic total occlusion (CTO) crossability. The NovaCross gains its supportive characteristics through the use of a unique operator-controlled Nitinol scaffold and an extandable segment, both at its distal tip.
干预措施: NovaCross (Device)
结局指标
主要结局
Primary Safety Measure - Rate of in-hospital MACE events
时间窗: up to 30 days
Defined as the composite of death, myocardial infarction (MI), or urgent revascularization (target vessel revascularization (TVR) or urgent coronary artery bypass surgery (CABG)).
Primary Outcome Measure - Intra-procedural technical succees
时间窗: Intra-procedure
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 (CTO) in the true vessel lumen
次要结局
- Outcome Measure - Technical adaptation of the Micro-catheter to the guidewire(Procedure)
- Outcome Measure - Ease of Use(Procedure)
- Outcome Measure - Rate of procedure success(Procedure)
- Outcome Measure - Effective micro-catheter crossability(Procedure)
- Safety Measure - Myocardial Infraction (MI) rate(up to 30 days)