Drug-Eluting Stent Implantation Versus Optimal Medical Treatment in Patients
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 840
- 试验地点
- 26
- 主要终点
- Composite outcomes of all cause death, myocardial infarction, stroke, and any revascularization for 3 years after randomization
研究概览
简要总结
The purpose of this study is to compare the safety and effectiveness of drug-eluting stent implantation compared to optimal medical treatment in patients with chronic total occlusion.
详细描述
Prospective, two arms, randomized multi-center trial in Asian-pacific region. Following angiography, patients with chronic total occlusion (more than 3 months) have documented myocardial ischemia or symptoms of angina, and eligible for stenting without any exclusion criteria will be randomized 1:1 to: a) drug-eluting stent vs. b) optimal medical treatment. All patients will be followed for at least 3 year.
The subjects with chronic total occlusion but failed to random for any reason, they will be enrolled in registry group.
The random design was closed at the date of 22 July 2019 however already randomized subjects and subjects from registry design continue 10 years follow-up on IRIS-CTO registry.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
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).
研究组 & 干预措施
Optimal medical therapy
optimal medical therapy
干预措施: optimal medical therapy (Drug)
drug-eluting stent
Cypher, xience, Endeavor, Taxus
干预措施: Cypher, xience, Endeavor, Taxus (Procedure)
结局指标
主要结局
Composite outcomes of all cause death, myocardial infarction, stroke, and any revascularization for 3 years after randomization
时间窗: at 3 years
at the median of 3 years
次要结局
- Angina class; Quality of life, clinical outcomes at 5 years(at 3 years & 5 years)
- Myocardial infarction, stroke,any revascularization, CTO-vessel related revascularization, hospitalization due to acute coronary syndrome, left ventricular ejection fraction(at 3 years & 5 years)
- All Death (Cardiac death)(at 3 years & 5 years)
研究者
Seung-Jung Park
MD,PhD, Chairman,Heart Institute, Asan Medical Center,University of Ulsan,College of Medicine
CardioVascular Research Foundation, Korea