KCT0009077尚未招募Unknown
Diabetes-Centered Evaluation of Revascularization Strategy of Functional and Imaging-CombiNEd State-of-the-Art Percutaneous Coronary Intervention or Coronary-Artery Bypass Grafting in Patients with Diabetes Mellitus and Multivessel Coronary Artery Disease
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 入组人数
- 1,360
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
- •Inclusion Criteria: subject must have met all of the following criteria to be eligible for treatment in the study:
- •1.The subject must be =20 years of age with angina and/or evidence of myocardial ischemia
- •2.Patients with type 2 diabetes based on the need for treatment with insulin or oral hypoglycemic drugs or a confirmed elevated blood glucose level (fasting plasma glucose elevation on >1 occasion of =126 mg/dL [7.0 mmol/L] or 2-h postprandial of =200 mg/dL [11.1 mmol/L] during oral glucose tolerance test or random plasma glucose of =200 mg/dL [11.1 mmol/L] with classic symptoms of hyperglycemia or hyperglycemic crisis or HbA1C =6.5% [48 mmol/mol]) (17).
- •3.Significant multivessel CAD (defined as = 50% diameter stenosis [DS] by visual estimation) of major epicardial vessels with LAD involvement and amenable to revascularization (equally suitable) by both PCI and CABG as determined by the Heart Team.
- •4.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 or Ethical Committee of the respective clinical site.
排除标准
- •Exclusion Criteria: Subjects were to be excluded from the study if any of the following criteria were met:
- •1.Unprotected left main coronary artery disease requiring revascularization
- •2.The presence of complex CAD 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 (<5 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 or non-cardiac surgical procedure (e.g., valve replacement, aorta surgery, or carotid revascularization). However, a maze procedure or pulmonary vein isolation is allowed
- •7.Contraindication or inability to take aspirin or P2Y12 inhibitors (clopidogrel, ticagrelor, or clopidogrel) for at least 6 months
- •8.Prior CABG
- •9.Extremely calcified or tortuous vessels precluding FFR measurement or intracoronary imaging evaluation
- •10.More than one major epicardial vessel which is chronically occluded; enrollment of 1 CTO lesion is allowed
- •11.Subjects requiring or who may require additional surgery (cardiac or noncardiac) within 1 year
- •12.End-stage renal disease requiring renal replacement therapy
- •13.Liver cirrhosis
- •14.Pregnant and/or lactating women
- •15.Concurrent medical condition with a limited life expectancy of less than 2 years
- •16.Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period, except for observational registries
研究者
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