Non-stenting Treatment Strategy for Acute Myocardial Infarction With Non-severe Stenosis(EROSION IV)
1 other identifier
interventional
2,000
1 country
47
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Apr 2026
Longer than P75 for not_applicable
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2026
CompletedFirst Submitted
Initial submission to the registry
April 21, 2026
CompletedFirst Posted
Study publicly available on registry
May 5, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2030
May 5, 2026
April 1, 2026
3 years
April 21, 2026
April 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Target Lesion Failure(TLF)
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.
Secondary Outcomes (13)
All-cause death
From randomization to the end of the study, median follow-up duration is 30 months.
Cardiovascular death
From randomization to the end of the study, median follow-up duration is 30 months.
Myocardial infarction (MI)
From randomization to the end of the study, median follow-up duration is 30 months.
Target vessel myocardial infarction
From randomization to the end of the study, median follow-up duration is 30 months.
Coronary Revascularization
From randomization to the end of the study, median follow-up duration is 30 months.
- +8 more secondary outcomes
Other Outcomes (6)
Definite or probable in-stent thrombosis
From randomization to the end of the study, median follow-up duration is 30 months.
Contrast-induced acute kidney injury(CI-AKI)
From randomization to the end of the study, median follow-up duration is 30 months.
Procedure-related myocardial infarction
From randomization to the end of the study, median follow-up duration is 30 months.
- +3 more other outcomes
Study Arms (2)
Guideline-recommended standard medical therapy alone
EXPERIMENTALDual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction.
DES implantation plus guideline-recommended standard medical therapy
ACTIVE COMPARATORDES implantation plus dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction.
Interventions
Dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction
DES implantation plus dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction.
Eligibility Criteria
You may qualify if:
- Male or female patients aged ≥18 years and ≤75 years;
- Diagnosis of type 1 AMI, including STEMI (onset \<24 hours or 7-14 days) or NSTEMI;
- 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);
- Reference diameter of the culprit lesion \>2.5 mm and ≤4.0 mm;
- Patients or a legally authorized representative must provide written Informed Consent prior to any study related procedure.
You may not qualify if:
- Severe cardiac dysfunction (Killip/NYHA class ≥ 3) or LVEF \< 30%;
- Cardiopulmonary resuscitation (CPR) performed at the onset of AMI;
- Persistent hemodynamic or cardiac electrical instability after TIMI flow restoration;
- Contraindication to antithrombotic drugs, or concurrent hemorrhagic diseases such as peptic ulcer or coagulation disorders;
- Contraindication to contrast;
- 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);
- Active liver disease, defined as known infectious, neoplastic, or metabolic liver lesions, with ALT and AST \>3× upper limit of normal (ULN);
- Previous history of CABG or PCI for the culprit lesion;
- Patients with other concurrent severe diseases and an expected life expectancy of \<1 year;
- Pregnant or lactating women. Women of childbearing potential must use effective contraceptive measures during the study treatment period;
- Inability to comply with the study protocol or other conditions deemed unsuitable for study participation by the investigator.
- Non-culprit lesion with DS ≥70% or planned revascularization;
- Left main coronary artery lesion with DS ≥50%;
- Culprit lesion is a true bifurcation lesion requiring a two-stent strategy;
- Long lesion (planned stent length \>60 mm);
- +6 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (47)
Beijing Luhe Hospital Affiliated to Capital Medical University
Beijing, China
Fuwai Hospital, Chinese Academy of Medical Sciences
Beijing, China
Cangzhou Central Hospital
Cangzhou, China
Chengde Medical College Affiliated Hospital
Chengde, China
Sichuan Provincial People's Hospital
Chengdu, China
The Central Hospital Affiliated to Dalian University of Technology
Dalian, China
The First Affiliated Hospital of Dalian Medical University
Dalian, China
The Second Affiliated Hospital of Dalian Medical University
Dalian, China
Daqing Oilfield General Hospital
Daqing, China
The Fourth Affiliated Hospital of Harbin Medical University
Harbin, China
The Third Xiangya Hospital of Central South University
Hunan, China
Central Hospital of Jiamusi City
Jiamusi, China
The First Affiliated Hospital of Jiamusi University
Jiamusi, China
China-Japan Union Hospital of Jilin University
Jilin, China
Jilin Central Hospital
Jilin, China
The First Hospital of Jilin University
Jilin, China
Shandong Provincial Hospital
Jinan, China
The Affiliated Hospital of Jining Medical University
Jining, China
Lanzhou University First Hospital
Lanzhou, China
Linyi People's Hospital
Linyi, China
Mudanjiang Cardiovascular Hospital
Mudanjiang, China
The First Affiliated Hospital of Nanyang Medical College
Nanyang, China
The Affiliated Hospital of Qingdao University
Qingdao, China
Qiqihar First Hospital
Qiqihar, China
The Second Affiliated Hospital of Qiqihar Medical University
Qiqihar, China
The Third Affiliated Hospital of Qiqihar Medical University
Qiqihar, China
Liaoning Provincial People's Hospital
Shenyang, China
Shengjing Hospital of China Medical University
Shenyang, China
The Fourth Affiliated Hospital of China Medical University
Shenyang, China
The Second Hospital of Hebei Medical University
Shijia Zhuang, China
Hebei Provincial People's Hospital
Shijiazhuang, China
Suihua First Hospital
Suihua, China
General Hospital of Taiyuan Iron and Steel (Group) Co.
Taiyuan, China
Shanxi Provincial Cardiovascular Hospital
Taiyuan, China
General Hospital of Tianjin Medical University
Tianjin, China
TEDA International Cardiovascular Hospital
Tianjin, China
Tianjin Chest Hospital
Tianjin, China
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, China
Wuhan Asia Heart Hospital
Wuhan, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, China
People's Hospital of Xinjiang Uygur Autonomous Region
Xinjiang, China
The First Affiliated Hospital of Xinjiang Medical University
Xinjiang, China
Yantai Yuhuangding Hospital
Yantai, China
Fuwai Huazhong Cardiovascular Hospital
Zhengzhou, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, China
Zunyi Medical University Affiliated Hospital
Zunyi, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bo Yu, Ph.D.
The Second Affiliated Hospital of Harbin Medical University
- PRINCIPAL INVESTIGATOR
Jingbo Hou, Ph.D.
The Second Affiliated Hospital of Harbin Medical University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- Outcomes assessor-blinded
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director, cardiology department, the second Affiliated Hospital of Harbin Medical University
Study Record Dates
First Submitted
April 21, 2026
First Posted
May 5, 2026
Study Start
April 1, 2026
Primary Completion (Estimated)
April 1, 2029
Study Completion (Estimated)
December 1, 2030
Last Updated
May 5, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share