NL-OMON41722已完成2 期
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. - NT-CLP-01
itiloop Ltd.0 个研究点目标入组 50 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Adult aged 25-80
- •2. Patient understands and has signed the study informed consent form.
- •3. Patient has an angiographic documented Chronic Total Occlusion (i.e. >3 months occlusion duration) showing distal TIMI flow 0.
- •4. Suitable candidate for non-emergent, coronary angioplasty
- •5. 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:
- •a) Thrombolysis in Myocardial Infarction (TIMI) 0 flow for at least 90 days;
- •b) Satisfactory distal vessel visualization
- •c) CTO should be amenable to percutaneous treatment and must be located in a coronary vessel with a reference diameter of at least 2 millimeters.
- •d) CTO refractory to a minimum of 10 minutes of conventional guide wire attempt.
- •6. Body Mass Index (BMI) < 40
- •7. Left ventricle ejection fraction > 25%
- •For the purpose of this trial, a CTO is defined as a 100% luminal narrowing without antegrade flow or
排除标准
- •1. Patient unable to give informed consent.
- •2. Current participation in another study with any investigational drug or device.
- •3. Patient is known or suspected not to tolerate the contrast agent.
- •4. Aorto-ostial CTO location (Ostial bifurcation origins may be considered), SVG CTO, in-stent CTO.
- •5. Intolerance to Aspirin and/or inability to tolerate a second antiplatelet agent (Clopidogrel and Prasugrel and Ticagrelor).
- •6. Appearance of a fresh thrombus or intraluminal filling defects.
- •7. Recent major cerebrovascular event (history of stroke or TIA within 1 month)
- •8. Cardiac intervention within 4 weeks of the procedure
- •9. Renal insufficiency (serum creatinine of > 2.3mg/dl or 203umol/L)
- •10. Active gastrointestinal bleeding
- •11. Active infection or fever that may be due to infection
- •12. Life expectancy < 2 years due to other illnesses
- •13. Significant anemia (hemoglobin < 8.0 mg / dl)
- •14. Severe uncontrolled systemic hypertension (> 240 mmHg within 1 month of procedure)
- •15. Severe electrolyte imbalance
- •16. Congestive heart failure [New York Heart Association (NYHA) Class III\IV] CSA Class IV.
- •17. Unstable angina requiring emergent percutaneous trans-luminal coronary angioplasty (PTCA) or coronary artery bypass graft (CABG)
- •18. Recent myocardial infarction (MI) (within the past two weeks)
- •19. Uncontrolled diabetes >2 serum glucose concentrations of >350 mg/dl within 7 days.
- •20. Unwillingness or inability to comply with any protocol requirements
- •21. Pregnant or nursing
- •22. Extensive prior dissection from a coronary guidewire use
- •23. Drug abuse or alcoholism.
- •24. Patients under custodial care.
- •25. Bleeding diathesis or coagulation disorder;
- •26. Kawasaki's disease or other vasculitis.
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