Evaluation of Effectiveness and Safety of Antegrade and Retrograde Approach of Percutaneous Coronary Intervention for Chronic Total Occlusions; Systemic Chronic Total Occlusion Revascularization Korea Research-Chronic Total Occlusion (STRIKE-CTO) Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 4,000
- 试验地点
- 64
- 主要终点
- Death
研究概览
简要总结
Objective of this study is to 1) analyze the clinical, anatomical and periprocedural differences of patients who underwent a procedure related to coronary CTO through the antergrade approach and retrograde approach; 2) analyze the success rate of the procedures and the incidence and patterns of complications; 3) compare and analyze long-term performances after the successful procedure; and 4) identify the independent factors that require a retrograde approach and the prognostic factor regarding long-term performances after use of each approach.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Patients aged>=19
- •Patients who have a CTO lesion in at least one or more epicardial coronary artery 2.5 mm in blood vessel diameter
- •Patients who have symptoms of angina or objectively proven myocardial ischemia (asymptomatic myocardial ischemia, stable or unstable angina, non - -ST-segment elevation myocardial infarction)
- •Patients who voluntarily agreed to the protocol and the clinical follow-up plan (or let their representative do this), and signed the informed consent form approved by the IRB of each study institute
排除标准
- •Patients who are pregnant or lactating or have childbearing potential Patients in whom contrast medium and heparin are contraindicated or who are hypersensitive to them
- •Patients in whom aspirin, clopidogrel, ticagrelor and prasugrel, cilostazol are contraindicated
- •Patients scheduled to undergo a surgery, etc. that requires discontinuance of an antiplatelet drug within 12 months after participation in the study
- •Acute ST elevation myocardial infarction at the time of hospitalization
- •Terminally ill patients with their life expectancy < one year
- •Patients who have serious diseases other than cardiac diseases that may affect limitation of residual life time or observation of the protocol (e.g. oxygen-independent chronic obstructive pulmonary disease, persisting hepatitis or serious hepatic insufficiency, severe renal disease, etc. Be left up to the discretion of the investigator.)
结局指标
主要结局
Death
时间窗: 12-month after PCI
Death
myocardial infarction
时间窗: 12-month after PCI
the periprocedural myocardial infarction under the SCAI definition or the non-lethal myocardial infarction during the follow-up observations
the complex endpoints of target vessel revascularization/reocclusion occurrence
时间窗: 12-month after PCI
including chronic total occlusion and angiostenosis
次要结局
- Myocardial infarction(every 1-year up-to 5-year)
- Procedure success rate(every 1-year up-to 5-year)
研究者
Seung-Whan Lee, M.D., Ph.D.
M.D.
Asan Medical Center