KCT0009073尚未招募Unknown
A Comparison of Fractional Flow Reserve- versus Angiography-Guided Percutaneous Coronary Intervention in Patients with Left Main Coronary Artery Disease
适应症
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 934
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
- 20(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •1. The subject must be =20 years of age with angina and/or evidence of myocardial ischemia
- •2. Significant de novo LMCA disease, defined as = 50% diameter stenosis by visual estimation with or without concomitant non-left main major epicardial CAD, amenable to PCI with DES implantation.
- •3. The patient or guardian agrees to the study protocol and the schedule of clinical follow-up, and provides informed, written consent, as approved by the appropriate Institutional Review Board/Ethical Committee of the respective clinical site.
排除标准
- •1.Extremely calcified or tortuous vessels precluding FFR measurement
- •2.The presence of complex coronary disease anatomy or lesion characteristics or other cardiac condition(s) which leads the participating interventional cardiologist to believe that PCI is not suitable (i.e. the subject should be managed with CABG or medical therapy alone)
- •3. Recent STEMI (<7 days prior to randomization)
- •4.Cardiogenic shock and/or need for mechanical/pharmacologic hemodynamic support
- •5.Severe left ventricular dysfunction (ejection fraction <30%)
- •6. Requirement for other cardiac surgical procedure (e.g., valve replacement or aorta surgery)
- •7.Contraindication or inability to take aspirin or P2Y12 inhibitors (clopidogrel, ticagrelor, or clopidogrel)
- •8.Prior PCI of the left main trunk
- •9.Prior CABG
- •10.Subjects requiring or who may require additional surgery (cardiac or noncardiac) within 1 year
- •11.End-stage renal disease requiring renal replacement therapy
- •12.Liver cirrhosis
- •13.Women who are pregnant or breastfeeding or female subjects, premenopausal who are not surgically sterile, or, if sexually active not practicing an effective method of birth control (e.g., prescription oral contraceptives, contraceptive injections, intrauterine device, double-barrier method, contraceptive patch, male partner sterilization) before entry and throughout the study; and, for those of childbearing potential, who have a positive pregnancy test at screening
- •14.Concurrent medical condition with a limited life expectancy of less than 2 years
- •15.Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period. However, where at least one or more conditions are satisfied, it could be an exception according to an investigator's discretion;
- •a.Participated in the observational study expected no effect on the safety and/or effectiveness evaluation of this trial
- •b.Screening failed before any interventional factor is involved
- •c.Participated in academic trials like strategic or medical device comparison studies conducted under standard therapy provided that there is no additional risk or a specific procedure to a subject and no interference between this trial and other studies
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