NCT07567625Recruiting
Non-stenting Treatment Strategy for Acute Myocardial Infarction With Non-severe Stenosis(EROSION IV)
Non-stenting Treatment Strategy for Acute Myocardial Infarction With Non-severe Stenosis: a Prospective, Multicenter, Open-label, Non-inferiority, Randomised Controlled Trial(EROSION IV)
Source: ClinicalTrials.gov · Last updated 16 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 2000 (estimated)
- First submitted
- 21 Apr 2026
- Start date
- 13 Jul 2026
- Primary completion date
- Apr 2029
- Lead sponsor
- Harbin Medical University
- Diseases
- Coronary artery disease
- NCT number
- NCT07567625
What you commit to
- Study type: Interventional
- Planned participants: 2000
- From 13 Jul 2026 to the primary completion date, Apr 2029
- 48 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Contraindication to antithrombotic drugs, or concurrent hemorrhagic diseases such as peptic ulcer or coagulation disorders;
- Previous history of CABG or PCI for the culprit lesion;
- Patients with other concurrent severe diseases and an expected life expectancy of \<1 year;
Other illness
- Persistent hemodynamic or cardiac electrical instability after TIMI flow restoration;
- Inability to comply with the study protocol or other conditions deemed unsuitable for study participation by the investigator.
- 2.Imaging exclusion criteria:
- Culprit lesion with dissection, false lumen, or other conditions necessitating stent implantation;
- Individuals who are allergic to adenosine triphosphate (ATP) or any component in its preparations;
- Second and third degree atrioventricular block, sick sinus syndrome (without artificial pacemaker protectors);
Lab values
- Severe cardiac dysfunction (Killip/NYHA class ≥ 3) or LVEF \< 30%;
- 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);
Other
- 1.Clinical exclusion criteria:
- Cardiopulmonary resuscitation (CPR) performed at the onset of AMI;
- Contraindication to contrast;
- Pregnant or lactating women. Women of childbearing potential must use effective contraceptive measures during the study treatment period;
- 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);
- Target lesion has undergone pre-treatment (such as balloon dilation, rotational atherectomy, etc.).
- 3.Functional sub study:
- Patients with bronchial asthma.
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (48)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Beijing Luhe Hospital affiliated to Capital Medical University Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| Fuwai Hospital Chinese Academy of Medical Sciences Coordinator of this site? Confirm its status | Beijing | China | Not yet recruiting |
| Cangzhou Central Hospital Coordinator of this site? Confirm its status | Cangzhou | China | Not yet recruiting |
| Chengde Medical College Affiliated Hospital Coordinator of this site? Confirm its status | Chengde | China | Not yet recruiting |
| Sichuan Provincial People's Hospital Coordinator of this site? Confirm its status | Chengdu | China | Not yet recruiting |
| The First Affiliated Hospital of Dalian Medical University Coordinator of this site? Confirm its status | Dalian | China | Not yet recruiting |
| The Second Affiliated Hospital of Dalian Medical University Coordinator of this site? Confirm its status | Dalian | China | Not yet recruiting |
| The Central Hospital Affiliated to Dalian University of Technology Coordinator of this site? Confirm its status | Dalian | China | Not yet recruiting |
| Daqing Oilfield General Hospital Coordinator of this site? Confirm its status | Daqing | China | Not yet recruiting |
| The Fourth Affiliated Hospital of Harbin Medical University Coordinator of this site? Confirm its status | Harbin | China | Not yet recruiting |
| The Second Affiliated Hospital of Harbin Medical University Coordinator of this site? Confirm its status | Harbin | China | Recruiting |
| The Third Xiangya Hospital of Central South University Coordinator of this site? Confirm its status | Hunan | China | Not yet recruiting |
| Central Hospital of Jiamusi City Coordinator of this site? Confirm its status | Jiamusi | China | Not yet recruiting |
| The First Affiliated Hospital of Jiamusi University Coordinator of this site? Confirm its status | Jiamusi | China | Not yet recruiting |
| China-Japan Union Hospital of Jilin University Coordinator of this site? Confirm its status | Jilin City | China | Not yet recruiting |
| Jilin Central Hospital Coordinator of this site? Confirm its status | Jilin City | China | Not yet recruiting |
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Jilin City | China | Not yet recruiting |
| Shandong Provincial Hospital Coordinator of this site? Confirm its status | Jinan | China | Not yet recruiting |
| The Affiliated Hospital of Jining Medical University Coordinator of this site? Confirm its status | Jining | China | Not yet recruiting |
| Lanzhou University First Hospital Coordinator of this site? Confirm its status | Lanzhou | China | Not yet recruiting |
| Linyi People's Hospital Coordinator of this site? Confirm its status | Linyi | China | Not yet recruiting |
| Mudanjiang Cardiovascular Hospital Coordinator of this site? Confirm its status | Mudanjiang | China | Not yet recruiting |
| The First Affiliated Hospital of Nanyang Medical College Coordinator of this site? Confirm its status | Nanyang | China | Not yet recruiting |
| The Affiliated Hospital of Qingdao University Coordinator of this site? Confirm its status | Qingdao | China | Not yet recruiting |
| The Second Affiliated Hospital of Qiqihar Medical University Coordinator of this site? Confirm its status | Qiqihar | China | Not yet recruiting |
| The Third Affiliated Hospital of Qiqihar Medical University Coordinator of this site? Confirm its status | Qiqihar | China | Not yet recruiting |
| Qiqihar First Hospital Coordinator of this site? Confirm its status | Qiqihar | China | Not yet recruiting |
| The Fourth Affiliated Hospital of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Not yet recruiting |
| Shengjing Hospital Of China Medical University Coordinator of this site? Confirm its status | Shenyang | China | Not yet recruiting |
| Liaoning Provincial People's Hospital Coordinator of this site? Confirm its status | Shenyang | China | Not yet recruiting |
| Hebei Provincial People's Hospital Coordinator of this site? Confirm its status | Shijiazhuang | China | Not yet recruiting |
| The Second Hospital of Hebei Medical University Coordinator of this site? Confirm its status | Shijia Zhuang | China | Not yet recruiting |
| Suihua First Hospital Coordinator of this site? Confirm its status | Suihua | China | Not yet recruiting |
| Shanxi Provincial Cardiovascular Hospital Coordinator of this site? Confirm its status | Taiyuan | China | Not yet recruiting |
| General Hospital of Taiyuan Iron and Steel (Group) Co. Coordinator of this site? Confirm its status | Taiyuan | China | Not yet recruiting |
| General Hospital of Tianjin Medical University Coordinator of this site? Confirm its status | Tianjin | China | Not yet recruiting |
| TEDA International Cardiovascular Hospital Coordinator of this site? Confirm its status | Tianjin | China | Not yet recruiting |
| Tianjin Chest Hospital Coordinator of this site? Confirm its status | Tianjin | China | Not yet recruiting |
| The Second Affiliated Hospital of Wenzhou Medical University Coordinator of this site? Confirm its status | Wenzhou | China | Not yet recruiting |
| Union Hospital, Tongji Medical College, Huazhong University of Science and Technology Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
| Wuhan Asia Heart Hospital Coordinator of this site? Confirm its status | Wuhan | China | Not yet recruiting |
| The First Affiliated Hospital of Xi'an Jiaotong University Coordinator of this site? Confirm its status | Xi’an | China | Not yet recruiting |
| The First Affiliated Hospital of Xinjiang Medical University Coordinator of this site? Confirm its status | Xinjiang | China | Not yet recruiting |
| People's Hospital of Xinjiang Uygur Autonomous Region Coordinator of this site? Confirm its status | Xinjiang | China | Not yet recruiting |
| Yantai Yuhuangding Hospital Coordinator of this site? Confirm its status | Yantai | China | Not yet recruiting |
| Fuwai Huazhong Cardiovascular Hospital Coordinator of this site? Confirm its status | Zhengzhou | China | Not yet recruiting |
| The First Affiliated Hospital of Zhengzhou University Coordinator of this site? Confirm its status | Zhengzhou | China | Not yet recruiting |
| Zunyi Medical University Affiliated Hospital Coordinator of this site? Confirm its status | Zunyi | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.