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
- 状态
- 已完成
- 发起方
- 入组人数
- 145
- 试验地点
- 9
- 主要终点
- Intra-procedural technical success
研究概览
简要总结
This study evaluates the safety and effectiveness of the a novel device called NovaCross to help cross Chronic Total Occlusion (CTO) lesions in coronary arteries.
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
- 18 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
- •Suitable candidate for non-emergent, coronary angioplasty
- •Documented coronary angiography preceding the PCI reveals at least one CTO lesion situated in a non-infarct related coronary artery or its side branches
- •Body Mass Index (BMI) < 40
- •Left ventricle ejection fraction > 25%
排除标准
- •Patient unable to give informed consent.
- •Current participation in another study with any investigational drug or device.
- •Patient is known or suspected not to tolerate the contrast agent.
- •Aorta-ostial CTO location (Ostial bifurcation origins may be considered), SVG CTO, in-stent 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 (history of stroke or TIA within 1 month)
- •Cardiac intervention within 4 weeks of the procedure
- •Renal insufficiency (serum creatinine of > 2.3mg/dl or 203μmol/L)
- •Active gastrointestinal bleeding
- •Active infection or fever that may be due to infection
- •Life expectancy < 2 years due to other illnesses
- •Significant anemia (hemoglobin < 8.0 mg / dl)
- •Severe uncontrolled systemic hypertension (> 240 mmHg within 1 month of procedure)
- •Severe electrolyte imbalance
- •Congestive heart failure [New York Heart Association (NYHA) Class III\IV] CSA Class IV.
- •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)
- •Uncontrolled diabetes >2 serum glucose concentrations of >350 mg/dl within 7 days.
- •Unwillingness or inability to comply with any protocol requirements
- •Pregnant or nursing
- •Extensive prior dissection from a coronary guidewire use
- •Drug abuse or alcoholism.
- •Patients under custodial care.
- •Bleeding diathesis or coagulation disorder;
- •Kawasaki's disease or other vasculitis
研究组 & 干预措施
NovaCross
NovaCross microcatheter will be used.
干预措施: NovaCross (Device)
结局指标
主要结局
Intra-procedural technical success
时间窗: Intra-procedure
Intra-procedural technical success, defined as the ability of the NovaCross™ micro-catheter to successfully facilitate placement of a guidewire beyond a native coronary chronic total occlusion (CTO) in the true vessel lumen.
MACE
时间窗: 30 days
30 day MACE, 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
- Proximal cap (ability of the NovaCross™ micro-catheter to facilitate a guidewire successfully penetrating the proximal cap of the CTO.)(Procedure)
- Effectiveness of extendable portion (effectiveness of the extendable portion in intra-CTO microcatheter crossability)(Procedure)
- Visualization (ability to have full visualization of the NovaCross during the CTO procedure)(Procedure)
- Device-related perforation (at the site of target coronary lesion and/or its proximal reference segment)(Procedure)
- 1. The ability to cross the lesion with a guidewire in the true lumen, effectively dilate the CTO lesion, and place a coronary stent with residual lumen stenosis of less than 30% while restoring antegrade TIMI 3 flow.(Procedure)
- Usability (Assess the usability of the NovaCross™ by the operator)(Procedure)