Yonsei OCT (Optical Coherence Tomography) Registry for Evaluation of Efficacy and Safety of Coronary Stenting
试验速览
- 阶段
- 不适用
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- Comparison of OCT findings with physiologic findings
研究概览
简要总结
Optical coherence tomography (OCT) has been recently studied for evaluation of coronary stenting. Because of high resolutions, several reports have shown that OCT is appropriate for evaluating neointimal tissue after coronary stent implantation. Also, the strut coverage and the characterization of neointimal tissue can be accurately evaluated. Furthermore, OCT-defined coverage of a stent strut was proposed to be related with clinical safety in drug-eluting stents-treated patients. Therefore, the investigators will evaluate the appropriateness of currently using coronary stents (e.g. Sirolimus eluting stent, Paclitaxel-eluting stent, Zotarolimus-eluting stent, Everolimus-eluting stent, Biolimus eluting stent, EPC(endothelial progenitor cell) Capture stent, etc) based on the findings of OCT. Additionally, the investigators will evaluate neointimal hyperplasia, malposition or strut coverage to decide the differences in the stent characteristics, the duration of antiplatelet use, and the differences according to the clinical presentations.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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 coronary stents
- •Patients who will have coronary stents because of coronary artery stenosis
排除标准
- •Hemodynamically unstable patients
- •Ostial lesions that begin within 15 mm of the left main coronary artery
- •Lesions with diameter more than 4 mm
- •Patients with allergy to antiplatelet agent (asprin or clopidogrel)
- •Patients with hepatic dysfunction (Liver enzyme 3 times the upper limit of normal)
- •Pregnant and lactating patients
- •Patients with life expectancy less than 1 year
结局指标
主要结局
Comparison of OCT findings with physiologic findings
时间窗: at index PCI, at follow-up coronary angiography (3, 6, 9 or 12 months and at the time clinically indicated)
OCT findings (stented lesions, native vessels)
时间窗: at index PCI, at follow-up coronary angiography (3, 6, 9 or 12 months and at the time clinically indicated)
Clinical outcomes
时间窗: up to 10 years
Death, Cardiac death, Stent thrombosis, Myocardial infarction, Target-lesion revascularization, Target-vessel revascularization
次要结局
未报告次要终点