NCT06908499招募中不适用
Ten-Year Outcomes of Randomized Comparison of Drug-eluting Stent Implantation Versus Optimal Medical Treatment in Patient With Chronic Total Occlusion: DECISION-CTO Trial
Seung-Jung Park33 个研究点 分布在 5 个国家目标入组 840 人开始时间: 2026年4月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 840
- 试验地点
- 33
- 主要终点
- Event rate of the composite event
研究概览
简要总结
The goal of this clinical trial is to compare long term efficacy of drug-eluting stent implantation compare to optimal medical treatment in patient with chronic total occlusion in a very long-term follow-up (minimum 10 years) period.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical 1) Patients with angina or silent ischemia and documented ischemia 2) Patients who are eligible for intracoronary stenting 3) Age >18 years
- •Angiographic 1) De novo lesion Chronic Total Occlusion (CTO) 2) Reference vessel size ≥ 2.5 mm by visual estimation 3) 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 (Thrombolysis in Myocardial Infarction) flow 0 or 1 with 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 CTOs
- •Known hypersensitivity or contra-indication to contrast agent and heparin
- •ST-elevation acute myocardial infarction requiring primary stenting
- •Culprit total occlusion presented with acute coronary syndrome suggesting acute or recent occlusion
- •Characteristics of lesion 1) Left main disease 2) In-stent restenosis 3) Graft vessels 4) Distal epicardial coronary artery CTO lesions 5) Two vessel proximal segment CTOs
- •Hematological disease (Neutropenia <3000/mm3, Thrombocytopenia <100,000/mm3)
- •Hepatic dysfunction, liver enzyme (ALT and AST) elevation ≥ 3 times normal
- •Renal dysfunction, creatinine ≥ 2.0mg/dL
- •Contraindication to aspirin, clopidogrel or other commercial antiplatelet agent
- •Left ventricular ejection fraction <30%
- •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
Patients with chronic total occlusion
Patients with chronic total occlusion who were enrolled in the original DECISION-CTO trial (NCT01078051)
结局指标
主要结局
Event rate of the composite event
时间窗: 10 years
The composite of all cause death, myocardial infarction, stroke and any revascularization at minimum of 10 years follow-up.
次要结局
- Event rate of any revascularization(10 years)
- Event rate of all cause death(10 years)
- Event rate of myocardial infarction(10 years)
- Event rate of stroke(10 years)
研究者
Seung-Jung Park
Principal Investigator
Asan Medical Center
研究点 (33)
Loading locations...
相似试验
已完成
4 期
Efficacy Study of Drug-eluting and Bare Metal Stents in Bypass Graft LesionsArteriosclerosis of Arterial Coronary Artery Bypass GraftNCT00611910Deutsches Herzzentrum Muenchen610
已完成
不适用
10-Years Follow-up of the EXAMINATION TrialST Elevation Myocardial InfarctionInfarctionNecrosisHeart DiseaseCardiovascular DiseasesVascular DiseasesMyocardial InfarctionNCT04462315Hospital Clinic of Barcelona1,498
已完成
不适用
Evaluating the Safety and Efficacy of the Maurora® DES in ICASStroke (CVA) or TIAIntracranial ArteriosclerosisNCT05719883Beijing Tiantan Hospital156
已完成
2 期
Drug Eluting Stents In The Critically Ischemic Lower LegCritical Limb IschemiaPeripheral Vascular DiseaseNCT00510393Flanders Medical Research Program140
已完成
不适用
Drug Eluting Stent Zilver PTX vs Bare Metal Stent Zilver FlexVascular DiseasesNCT05296031Skane University Hospital49