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

RecruitingNAAges 18 Years - 75 YearsAllHarbin Medical University
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In plain words

What the trial is, and whether it could suit you

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-

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📋 Eligibility rules (as published)
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.
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What it tests

  • Guideline-recommended standard medical therapy alone
  • DES implantation plus guideline-recommended standard medical therapy
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Where

48 sites
The Second Affiliated Hospital of Harbin Medical University
Harbin, China
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

…and 40 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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