临床试验/NCT04444960

NCT04444960Unknown不适用

Prospective Registry of the Intracoronary Physiology and Imaging-guided Precision Therapy in Complex High-risk Patients

First Affiliated Hospital Xi'an Jiaotong University1 个研究点分布在 1 个国家目标入组 1,000 人开始时间: 2020年7月1日最近更新: 2020年8月21日

适应症

试验速览

阶段: 不适用
发起方: First Affiliated Hospital Xi'an Jiaotong University
入组人数: 1,000
试验地点: 1
主要终点: Composite ischemic events

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

This is a prospective registry to enroll complex high-risk coronary heart disease patients.

The purpose of this study is to compare intracoronary physiology and imaging-guided intervention strategy and angiography-guided intervention strategy for clinical outcomes and health economics.

研究设计

研究类型: Observational
观察模型: Case Only
时间视角: Prospective

入排标准

性别: All
接受健康志愿者: 否

入选标准

•Bifurcation lesions with branch diameter ≥2.5mm;
•Chronic complete occlusion (occlusion duration ≥3 months);
•Left main disease;
•Long lesions (≥38mm);
•Multi-vessel percutaneous coronary intervention (simultaneous treatment of ≥2 epicardial vessels during one operation);
•Multi-stent implantation (≥3 stents);
•In-stent restenosis;
•Moderate to severe calcification on radiography;
•Intermediate lesion;
•Thrombotic lesions;
•Creatinine clearance rate < 60ml/min) or on dialysis ;
•Left ventricular ejection fraction <40% ；
•History of cerebral hemorrhage or massive hemorrhage of gastrointestinal tract.

排除标准

•Informed consent cannot be obtained;
•Life expectancy < 1 year.

结局指标

主要结局

Composite ischemic events

时间窗: 24 months

Composite ischemic event is defined as the composite of cardiac death, stent thrombosis, nonfatal myocardial infarction or ischemic driven revascularization.

次要结局

未报告次要终点

研究者

发起方

First Affiliated Hospital Xi'an Jiaotong University

申办方类型

Other

责任方

Sponsor

研究点 (1)

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