KCT0002918终止未知
Drug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients With Chronic Total Occlusion
试验速览
- 阶段
- 未知
- 状态
- 终止
- 入组人数
- 834
研究概览
简要总结
CTO-PCI was feasible with high success rates. There was no difference in the incidence of major adverse cardiovascular events with CTO-PCI versus no CTO-PCI, but the study was limited by low power for clinical end points and high crossover rates between groups.
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •Patients with angina or silent ischemia and documented ischemia
- •Patients who are eligible for intracoronary stenting
- •Age > 18 years
- •Angiographic
- •De novo lesion CTO
- •Reference vessel size 2.5 mm by visual estimation
- •At least one CTO lesions located in proximal or mid epicardial coronary artery. (If the patient has two CTO lesions, one CTO lesion should be located in proximal or mid epicardial coronary artery)
- •CTO definition: TIMI flow 0 and estimated duration over 3 months The duration of the occlusion was determined by the interval from the last episode of acute coronary syndrome, or In patients without a history of acute coronary syndrome, from the first episode of effort angina consistent with the location of the occlusion
- •Angiographically defined total occlusion over 3 months
- •If no definite symptom with total occlusion, two experienced operators decide CTO in consideration of angiographical morphology (degree of calcification, bridging collaterals, non-tapered stump, angiographic filling from collaterals)
排除标准
- •History of bleeding diathesis or coagulopathy
- •Pregnant state
- •Three vessel CTO
- •Known hypersensitivity or contra-indication to contrast agent and heparin
- •ST-elevation acute myocardial infarction requiring primary stenting
- •Characteristics of lesion 1) Left main disease 2) In-stent restenosis 3) Graft vessels 4) Distal epicardial coronary artery CTO lesions
- •Hematological disease
- •Hepatic dysfunction, liver enzyme (ALT and AST) elevation 3 times normal
- •Renal dysfunction, creatinine more than 2.0
- •Contraindication to aspirin, clopidogrel or other commercial antiplatelet agent
- •Left ventricular ejection fraction
- •Patients who are actively participating in another drug or device investigational study, which have not completed the primary endpoint follow-up period.
- •Non-cardiac co-morbid conditions are present with limited life expectancy or that may result in protocol non-compliance (per site investigator's medical judgment).
研究者
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