NCT01978860已完成不适用
A Prospective, First in Man Study to Evaluate the Safety and Performance of the NovaCross™ Micro-catheter in (CTO) Coronary Lesions
Chanan Schneider1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2013年11月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- lack of device related major adverse event
研究概览
简要总结
This is a prospective, non-randomized, first-in-man investigational study, to assess the safety and technical feasibility, deployment and withdrawal characteristics of the NovaCross™ micro-catheter during an interventional coronary angioplasty procedure and evaluating the CTO penetration rate.
Each study subject/patient will have a total of one (1) procedure performed for this study.
详细描述
To be filled later
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
- •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 with the following characteristics:
- •Thrombolysis in Myocardial Infarction (TIMI) 0 flow for at least 90 days;
- •Satisfactory distal vessel visualization
- •CTO should be amenable to percutaneous treatment and must be located in a coronary vessel with a reference diameter of at least 2 millimeters.
- •CTO refractory to a minimum of 10 minutes of conventional guide wire attempt.
- •Body Mass Index (BMI) < 40
- •Left ventricle ejection fraction > 25%
- •For the purpose of this trial, a CTO is defined as a 100% luminal narrowing without antegrade flow or with antegrade or retrograde filling through collateral vessels.
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.
- •Aorto-ostial CTO location (Ostial bifurcation origins may be considered), SVG CTO and in-stent CTOs.
- •Intolerance to aspirin or Clopidogrel or Prasugrel or Ticagrelor medications
- •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)
- •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.
- •Participation in another investigational protocol
- •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.
结局指标
主要结局
lack of device related major adverse event
时间窗: 30 days
. 30-day Lack of device-related Major Adverse Cardiac Event Rate (MACE) at the site of target coronary lesion and/or its proximal reference segment. Time Frame:
次要结局
- Maneuverability of the NovaCross ™ up to the occlusion and safe withdrawal(During Procedure)
研究者
Chanan Schneider
COO
Nitiloop Ltd.
研究点 (1)
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