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Non-stenting Treatment Strategy for Acute Myocardial Infarction With Non-severe Stenosis(EROSION IV)

2026年7月14日 更新者：Yu Bo、Harbin Medical University

Non-stenting Treatment Strategy for Acute Myocardial Infarction With Non-severe Stenosis: a Prospective, Multicenter, Open-label, Non-inferiority, Randomised Controlled Trial(EROSION IV)

This study is a prospective, multicenter, open-label, non-inferiority, randomized controlled trial. A total of 2,000 patients with STEMI (<24 hours or 7-14 days) or NSTEMI will be recruited from at least 20 centers in China. Eligible patients must have residual DS < 70% at the culprit lesion assessed by QCA, with optional thrombus aspiration, and TIMI flow of grade 3. Patients will be randomly assigned in a 1:1 ratio to the experimental group or the control group. The planned enrollment period is 36 months, and all patients will be followed up for at least 12 months after randomization, with continued follow-up until the end of the study. The primary outcome is the first occurrence of TLF after randomization, defined as the composite of cardiovascular death, target vessel myocardial infarction, ischemia-driven target lesion revascularization. The study aims to verify whether guideline-recommended standard medical therapy is non-inferior to DES implantation combined with guideline-recommended standard medical therapy in AMI patients with non-severe coronary artery stenosis.

A total of 120 participants (60 in the experimental group and 60 in the control group) enrolled at the Second Affiliated Hospital of Harbin Medical University were included in the functional substudy. Using Abbott Pressure Wire™X pressure wire test functional indicators, and explore the incidence of coronary microvascular dysfunction (CMD) as assessed by the index of microcirculatory resistance (IMR) in two groups, and its impact on the rate of the composite endpoint of all-cause death and heart failure readmission occurring for the first time within 12 months.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

2000

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

  • 中国
      • Beijing、中国
        • 尚未招聘
        • Fuwai Hospital, Chinese Academy of Medical Sciences
        • 接触：
          • Lei Song
      • Beijing、中国
        • 尚未招聘
        • Beijing Luhe Hospital Affiliated to Capital Medical University
        • 接触：
          • Guangyao Zhai
      • Cangzhou、中国
        • 尚未招聘
        • Cangzhou Central Hospital
        • 接触：
          • Jun Zhang
      • Chengde、中国
        • 尚未招聘
        • Chengde Medical College Affiliated Hospital
        • 接触：
          • Ying Zhang
      • Chengdu、中国
        • 尚未招聘
        • Sichuan Provincial People's Hospital
        • 接触：
          • Wenjie Tian
      • Dalian、中国
        • 尚未招聘
        • The First Affiliated Hospital of Dalian Medical University
        • 接触：
          • Bo Zhang
      • Dalian、中国
        • 尚未招聘
        • The Second Affiliated Hospital of Dalian Medical University
        • 接触：
          • Xin Zhao
      • Dalian、中国
        • 尚未招聘
        • The Central Hospital Affiliated to Dalian University of Technology
        • 接触：
          • Xiaoqun Zheng
      • Daqing、中国
        • 尚未招聘
        • Daqing Oilfield General Hospital
        • 接触：
          • Zhiqi Sun
      • Harbin、中国
        • 尚未招聘
        • The Fourth Affiliated Hospital of Harbin Medical University
        • 接触：
          • Wei Yang
      • Hunan、中国
        • 尚未招聘
        • The Third XIANGYA Hospital of Central South University
        • 接触：
          • Yu Cao
      • Jiamusi、中国
        • 尚未招聘
        • Central Hospital of Jiamusi City
        • 接触：
          • Zhiyuan Weng
      • Jiamusi、中国
        • 尚未招聘
        • The First Affiliated Hospital of Jiamusi University
        • 接触：
          • Guangyuan Yang
      • Jilin City、中国
        • 尚未招聘
        • China-Japan Union Hospital of Jilin University
        • 接触：
          • Yuquan He
      • Jilin City、中国
        • 尚未招聘
        • Jilin Central Hospital
        • 接触：
          • Yijun Shang
      • Jilin City、中国
        • 尚未招聘
        • The First Hospital of Jilin University
        • 接触：
          • Qian Tong
      • Jinan、中国
        • 尚未招聘
        • Shandong Provincial Hospital
        • 接触：
          • Haitao Yuan
      • Jining、中国
        • 尚未招聘
        • The Affiliated Hospital of Jining Medical University
        • 接触：
          • Lijun Gan
      • Lanzhou、中国
        • 尚未招聘
        • Lanzhou University First Hospital
        • 接触：
          • Ming Bai
      • Linyi、中国
        • 尚未招聘
        • Linyi People's Hospital
        • 接触：
          • Yanjin Wei
      • Mudanjiang、中国
        • 尚未招聘
        • Mudanjiang Cardiovascular Hospital
        • 接触：
          • Kai Liu
      • Nanyang、中国
        • 尚未招聘
        • The First Affiliated Hospital of Nanyang Medical College
        • 接触：
          • Ou Zhang
      • Qingdao、中国
        • 尚未招聘
        • The Affiliated Hospital of Qingdao University
        • 接触：
          • Zhexun Lian
      • Qiqihar、中国
        • 尚未招聘
        • Qiqihar First Hospital
        • 接触：
          • Jinhui Zhang
      • Qiqihar、中国
        • 尚未招聘
        • The Second Affiliated Hospital of Qiqihar Medical University
        • 接触：
          • Xiaojie Wu
      • Qiqihar、中国
        • 尚未招聘
        • The Third Affiliated Hospital of Qiqihar Medical University
        • 接触：
          • Haifeng Shao
      • Shenyang、中国
        • 尚未招聘
        • Shengjing Hospital of China Medical University
        • 接触：
          • Zhijun Sun
      • Shenyang、中国
        • 尚未招聘
        • The Fourth Affiliated Hospital of China Medical University
        • 接触：
          • Yuanzhe Jin
      • Shenyang、中国
        • 尚未招聘
        • Liaoning Provincial People's Hospital
        • 接触：
          • Bo Luan
      • Shijia Zhuang、中国
        • 尚未招聘
        • The Second Hospital of Hebei Medical University
        • 接触：
          • Xinshun Gu
      • Shijiazhuang、中国
        • 尚未招聘
        • Hebei Provincial People's Hospital
        • 接触：
          • Yi Dang
      • Suihua、中国
        • 尚未招聘
        • Suihua First Hospital
        • 接触：
          • Qiuye Yang
      • Taiyuan、中国
        • 尚未招聘
        • General Hospital of Taiyuan Iron and Steel (Group) Co.
        • 接触：
          • Huifeng Wang
      • Taiyuan、中国
        • 尚未招聘
        • Shanxi Provincial Cardiovascular Hospital
        • 接触：
          • Zhulin Zhang
      • Tianjin、中国
        • 尚未招聘
        • Tianjin Chest Hospital
        • 接触：
          • Chunjie Li
      • Tianjin、中国
        • 尚未招聘
        • Teda International Cardiovascular Hospital
        • 接触：
          • Wenhua Lin
      • Tianjin、中国
        • 尚未招聘
        • General Hospital of Tianjin Medical University
        • 接触：
          • Qing Yang
      • Wenzhou、中国
        • 尚未招聘
        • The Second Affiliated Hospital of Wenzhou Medical University
        • 接触：
          • Xueqiang Guan
      • Wuhan、中国
        • 尚未招聘
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • 接触：
          • Xiang Cheng
      • Wuhan、中国
        • 尚未招聘
        • Wuhan Asia Heart Hospital
        • 接触：
          • Hua Yan
      • Xi'an、中国
        • 尚未招聘
        • The First Affiliated Hospital of Xi'an Jiaotong University
        • 接触：
          • Zuyi Yuan
      • Xinjiang、中国
        • 尚未招聘
        • The First Affiliated Hospital of Xinjiang Medical University
        • 接触：
          • Xiang Ma
      • Xinjiang、中国
        • 尚未招聘
        • People's Hospital of Xinjiang Uygur Autonomous Region
        • 接触：
          • Yining Yang
      • Yantai、中国
        • 尚未招聘
        • Yantai YuHuangDing Hospital
        • 接触：
          • Faxin Ren
      • Zhengzhou、中国
        • 尚未招聘
        • The First Affiliated Hospital of Zhengzhou University
        • 接触：
          • Jinying Zhang
      • Zhengzhou、中国
        • 尚未招聘
        • Fuwai Huazhong Cardiovascular Hospital
        • 接触：
          • Chuanyu Gao
      • Zunyi、中国
        • 尚未招聘
        • Zunyi Medical University Affiliated Hospital
        • 接触：
          • Ranzun Zhao
    • Heilongjiang
      • Harbin、Heilongjiang、中国、150086
        • 招聘中
        • The Second Affiliated Hospital of Harbin Medical University
        • 接触：

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  1. Male or female patients aged ≥18 years and ≤75 years;
  2. Diagnosis of type 1 AMI, including STEMI (onset <24 hours or 7-14 days) or NSTEMI;
  3. After coronary angiography (CAG) ± thrombus aspiration, TIMI flow in the culprit vessel is restored to grade 3 and maintained for at least 5 minutes, with diameter stenosis (DS) <70% at the culprit lesion (QCA);
  4. Reference diameter of the culprit lesion >2.5 mm and ≤4.0 mm;
  5. Patients or a legally authorized representative must provide written Informed Consent prior to any study related procedure.

Exclusion Criteria:

1.Clinical exclusion criteria:

  1. Severe cardiac dysfunction (Killip/NYHA class ≥ 3) or LVEF < 30%;
  2. Cardiopulmonary resuscitation (CPR) performed at the onset of AMI;
  3. Persistent hemodynamic or cardiac electrical instability after TIMI flow restoration;
  4. Contraindication to antithrombotic drugs, or concurrent hemorrhagic diseases such as peptic ulcer or coagulation disorders;
  5. Contraindication to contrast;
  6. Severe renal dysfunction [defined as eGFR ≤30 ml/min/1.73m² or Scr ≥2.0 mg/dL] without regular dialysis (patients with chronic renal insufficiency on regular dialysis may be considered for enrollment);
  7. Active liver disease, defined as known infectious, neoplastic, or metabolic liver lesions, with ALT and AST >3× upper limit of normal (ULN);
  8. Previous history of CABG or PCI for the culprit lesion;
  9. Patients with other concurrent severe diseases and an expected life expectancy of <1 year;
  10. Pregnant or lactating women. Women of childbearing potential must use effective contraceptive measures during the study treatment period;
  11. Inability to comply with the study protocol or other conditions deemed unsuitable for study participation by the investigator.

2.Imaging exclusion criteria:

  1. Non-culprit lesion with DS ≥70% or planned revascularization;
  2. Left main coronary artery lesion with DS ≥50%;
  3. Culprit lesion is a true bifurcation lesion requiring a two-stent strategy;
  4. Long lesion (planned stent length >60 mm);
  5. Culprit lesion with dissection, false lumen, or other conditions necessitating stent implantation;
  6. Target lesion has undergone pre-treatment (such as balloon dilation, rotational atherectomy, etc.).

3.Functional sub study:

  1. Individuals who are allergic to adenosine triphosphate (ATP) or any component in its preparations;
  2. Second and third degree atrioventricular block, sick sinus syndrome (without artificial pacemaker protectors);
  3. Patients with bronchial asthma.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
实验性的：Guideline-recommended standard medical therapy alone
Dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction.
药品：Guideline-recommended standard medical therapy alone
Dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction
有源比较器：DES implantation plus guideline-recommended standard medical therapy
DES implantation plus dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction.
程序：DES implantation plus guideline-recommended standard medical therapy
DES implantation plus dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction.

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
Target Lesion Failure(TLF)
大体时间：From randomization to the end of the study, median follow-up duration is 30 months.
TLF is defined as a composite endpoint consisting of cardiovascular death, target vessel myocardial infarction and ischemia-driven target lesion revascularization.
From randomization to the end of the study, median follow-up duration is 30 months.

次要结果测量

结果测量
措施说明
大体时间
All-cause death
大体时间：From randomization to the end of the study, median follow-up duration is 30 months.
From randomization to the end of the study, median follow-up duration is 30 months.
Cardiovascular death
大体时间：From randomization to the end of the study, median follow-up duration is 30 months.
From randomization to the end of the study, median follow-up duration is 30 months.
Myocardial infarction (MI)
大体时间：From randomization to the end of the study, median follow-up duration is 30 months.
From randomization to the end of the study, median follow-up duration is 30 months.
Target vessel myocardial infarction
大体时间：From randomization to the end of the study, median follow-up duration is 30 months.
From randomization to the end of the study, median follow-up duration is 30 months.
Coronary Revascularization
大体时间：From randomization to the end of the study, median follow-up duration is 30 months.
From randomization to the end of the study, median follow-up duration is 30 months.
Target vessel revascularization
大体时间：From randomization to the end of the study, median follow-up duration is 30 months.
From randomization to the end of the study, median follow-up duration is 30 months.
Target lesion revascularization
大体时间：From randomization to the end of the study, median follow-up duration is 30 months.
From randomization to the end of the study, median follow-up duration is 30 months.
Ischemia-driven target lesion revascularization
大体时间：From randomization to the end of the study, median follow-up duration is 30 months.
From randomization to the end of the study, median follow-up duration is 30 months.
Stroke
大体时间：From randomization to the end of the study, median follow-up duration is 30 months.
From randomization to the end of the study, median follow-up duration is 30 months.
Rehospitalization for unstable angina pectoris
大体时间：From randomization to the end of the study, median follow-up duration is 30 months.
From randomization to the end of the study, median follow-up duration is 30 months.
Rehospitalization for heart failure
大体时间：From randomization to the end of the study, median follow-up duration is 30 months.
From randomization to the end of the study, median follow-up duration is 30 months.
Major adverse cardiovascular and cerebrovascular events (MACCE)
大体时间：From randomization to the end of the study, median follow-up duration is 30 months.
MACCE: defined as a composite endpoint consisting of all-cause death, myocardial infarction, stroke, and repeat revascularization.
From randomization to the end of the study, median follow-up duration is 30 months.
Seattle Angina Questionnaire(SAQ)score
大体时间：From 24 hours after surgery to discharge and the 12th month after discharge
From 24 hours after surgery to discharge and the 12th month after discharge

其他结果措施

结果测量
措施说明
大体时间
Definite or probable in-stent thrombosis
大体时间：From randomization to the end of the study, median follow-up duration is 30 months.
Safety endpoint
From randomization to the end of the study, median follow-up duration is 30 months.
Contrast-induced acute kidney injury(CI-AKI)
大体时间：From randomization to the end of the study, median follow-up duration is 30 months.
Safety endpoint
From randomization to the end of the study, median follow-up duration is 30 months.
Procedure-related myocardial infarction
大体时间：From randomization to the end of the study, median follow-up duration is 30 months.
Safety endpoint
From randomization to the end of the study, median follow-up duration is 30 months.
Bleeding Academic Research Consortium(BARC)type 3 and type 5 bleeding
大体时间：From randomization to the end of the study, median follow-up duration is 30 months.
Safety endpoint
From randomization to the end of the study, median follow-up duration is 30 months.
Microcirculation resistance index(IMR)to assess the incidence of coronary microvascular dysfunction (CMD)
大体时间：From randomization to the end of the study, median follow-up duration is 30 months.
Exploratory endpoint:Functional sub research
From randomization to the end of the study, median follow-up duration is 30 months.
The first occurrence of all-cause death and readmission due to heart failure within 12 months.
大体时间：From randomization to the 12th month.
Exploratory endpoint:Functional sub research
From randomization to the 12th month.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Harbin Medical University

调查人员

  • 首席研究员：Bo Yu, Ph.D.、The Second Affiliated Hospital of Harbin Medical University
  • 首席研究员：Jingbo Hou, Ph.D.、The Second Affiliated Hospital of Harbin Medical University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年7月13日

初级完成 (估计的)

2029年4月1日

研究完成 (估计的)

2030年12月1日

研究注册日期

首次提交

2026年4月21日

首先提交符合 QC 标准的

2026年4月30日

首次发布 (实际的)

2026年5月5日

研究记录更新

最后更新发布 (实际的)

2026年7月16日

上次提交的符合 QC 标准的更新

2026年7月14日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • KY2026-042

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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