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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 3
- 主要终点
- Primary Efficacy Endpoint - Intra-procedural technical success
研究概览
简要总结
This study will include up to 60 eligible male and female subjects. The purpose of this trial is to evaluate the safety and effectiveness of the NovaCross™ micro-catheter when used to facilitate crossing of Chronic Total Occlusion (CTO) lesions in coronary arteries. The procedure will be conducted on consenting patients diagnosed with a CTO in a coronary vessel that requires revascularization after a previously failed attempt to cross or refractory to 10 minutes of conventional guidewire attempt. This study is an extension study of Nitiloop's Pivotal study.
详细描述
The purpose of this trial is to evaluate the safety and effectiveness of the NovaCross™ micro-catheter when used to facilitate crossing of Chronic Total Occlusion (CTO) lesions in coronary arteries. The procedure will be conducted on consenting patients diagnosed with a CTO in a coronary vessel that requires revascularization after a previously failed attempt to cross or refractory to 10 minutes of conventional guidewire attempt.
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)
结局指标
主要结局
Primary Efficacy Endpoint - Intra-procedural technical success
时间窗: during the procedure
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
Primary Safety Endpoint - Rate of In hospital MACE events
时间窗: until discharge or 30 days, the sooner of the two
defined as the composite of death, myocardial infarction (MI), or urgent revascularization (target vessel revascularization (TVR) or urgent coronary artery bypass surgery (CABG)).
次要结局
- Rate of Lesion Crossing(during the procedure)
- Investigator visualization and ease of use(during the procedure)
- Crossability(during the procedure)
- Myocardial Infraction (MI) Rate(up to 30 days)
- Device Related Adverse Events(up to 30 days)
- Guidewire Facilitation and rate of successful penetration to the CTO(during the procedure)