KCT0008679已完成Unknown
Safety and efficacy of Cardiac mapping system workstation ‘AVIAR (MX-02)’ in patients undergoing percutaneous coronary intervention (PCI): prospective, multi-center, single-arm, open, post-approval clinical trial
适应症
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 21
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 19(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •General Inclusion Criteria:
- •1.Adult women and men who are aged =19 and <75 years
- •2.Those who are suspected of stable angina and need percutaneous coronary intervention
- •3.Those who voluntarily decided to participate in this clinical trial and agreed in writing to the informed consent form
- •4.Those who are willing to comply with the protocol
- •Angiographic Inclusion Criteria:
- •1.If the lesion to be treated by coronary angiography (target lesion) is a native coronary artery lesion that has not been previously treated
- •2.If the diameter of the lesioned vessel to be treated by coronary angiography (target vessel) is between 2.5 mm and 4.5 mm (by visual estimate).
- •3.If diameter stenosis of the target vessel =50% (by visual estimate)
排除标准
- •General Exclusion Criteria:
- •1.Those with a left ventricular ejection fraction (LVEF) = 30%
- •2.Those who have a history of hypersensitivity to contrast agents such as stainless steel, cobalt-chromium, etc.
- •3.Those who cannot stop taking antithrombotic drugs (anticoagulants, antiplatelet drugs)
- •4.Those diagnosed with thrombocytopenia, thrombocytosis, neutropenia, or leukopenia
- •5.Those who have a history of bleeding diathesis or coagulopathy or who refuse transfusion
- •6.Those with a history of stroke (CVA) or transient ischemic attack (TIA) within 4 weeks from the screening date
- •7..Those with a history of active peptic ulcer or upper gastrointestinal bleeding within 24 weeks from the screening date
- •8.Those with ST-elevation myocardial infarction (STEMI) (for example, those who started myocardial infarction symptoms within 72 hours from the screening date)
- •9.Those with a history of cardiogenic shock or cardiac arrest
- •10.Those who underwent coronary artery bypass grafting (CABG)
- •11.Those who underwent percutaneous coronary intervention (PCI) within 72 hours from the screening date
- •12.Those who had a major adverse coronary event (MACE) or a serious adverse event (SAE) after receiving the percutaneous coronary intervention (PCI) within 4 weeks from the screening date
- •13.Those who are scheduled to undergo percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG) within 4 weeks from the end of this clinical trial
- •14.Those diagnosed with renal failure or those who are not suitable for angiography due to severe renal dysfunction (creatine > 2.0 mg/dL or eGFR (estimated glomerular filtration rate) < 30 ml/min) within one week prior to the date of coronary angiography
- •15.Pregnant and breastfeeding women
- •16.Women of childbearing potential who plan to become pregnant during this clinical trial
- •17.A woman* or spouse who is likely to be pregnant does not agree to use contraception in a medically acceptable method of contraception** during the clinical trial
研究者
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