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

Status: Recruiting
Location: See all (48) locations...
Intervention Type: Procedure, Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Beijing Luhe Hospital Affiliated to Capital Medical University
NOT_YET_RECRUITING
Beijing
Fuwai Hospital, Chinese Academy of Medical Sciences
NOT_YET_RECRUITING
Beijing
Cangzhou Central Hospital
NOT_YET_RECRUITING
Cangzhou
Chengde Medical College Affiliated Hospital
NOT_YET_RECRUITING
Chengde
Sichuan Provincial People's Hospital
NOT_YET_RECRUITING
Chengdu
The Central Hospital Affiliated to Dalian University of Technology
NOT_YET_RECRUITING
Dalian
The First Affiliated Hospital of Dalian Medical University
NOT_YET_RECRUITING
Dalian
The Second Affiliated Hospital of Dalian Medical University
NOT_YET_RECRUITING
Dalian
Daqing Oilfield General Hospital
NOT_YET_RECRUITING
Daqing
The Fourth Affiliated Hospital of Harbin Medical University
NOT_YET_RECRUITING
Harbin
The Second Affiliated Hospital of Harbin Medical University
RECRUITING
Harbin
The Third Xiangya Hospital of Central South University
NOT_YET_RECRUITING
Hunan
Central Hospital of Jiamusi City
NOT_YET_RECRUITING
Jiamusi
The First Affiliated Hospital of Jiamusi University
NOT_YET_RECRUITING
Jiamusi
China-Japan Union Hospital of Jilin University
NOT_YET_RECRUITING
Jilin City
Jilin Central Hospital
NOT_YET_RECRUITING
Jilin City
The First Hospital of Jilin University
NOT_YET_RECRUITING
Jilin City
Shandong Provincial Hospital
NOT_YET_RECRUITING
Jinan
The Affiliated Hospital of Jining Medical University
NOT_YET_RECRUITING
Jining
Lanzhou University First Hospital
NOT_YET_RECRUITING
Lanzhou
Linyi People's Hospital
NOT_YET_RECRUITING
Linyi
Mudanjiang Cardiovascular Hospital
NOT_YET_RECRUITING
Mudanjiang
The First Affiliated Hospital of Nanyang Medical College
NOT_YET_RECRUITING
Nanyang
The Affiliated Hospital of Qingdao University
NOT_YET_RECRUITING
Qingdao
Qiqihar First Hospital
NOT_YET_RECRUITING
Qiqihar
The Second Affiliated Hospital of Qiqihar Medical University
NOT_YET_RECRUITING
Qiqihar
The Third Affiliated Hospital of Qiqihar Medical University
NOT_YET_RECRUITING
Qiqihar
Liaoning Provincial People's Hospital
NOT_YET_RECRUITING
Shenyang
Shengjing Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
The Fourth Affiliated Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
The Second Hospital of Hebei Medical University
NOT_YET_RECRUITING
Shijia Zhuang
Hebei Provincial People's Hospital
NOT_YET_RECRUITING
Shijiazhuang
Suihua First Hospital
NOT_YET_RECRUITING
Suihua
General Hospital of Taiyuan Iron and Steel (Group) Co.
NOT_YET_RECRUITING
Taiyuan
Shanxi Provincial Cardiovascular Hospital
NOT_YET_RECRUITING
Taiyuan
General Hospital of Tianjin Medical University
NOT_YET_RECRUITING
Tianjin
TEDA International Cardiovascular Hospital
NOT_YET_RECRUITING
Tianjin
Tianjin Chest Hospital
NOT_YET_RECRUITING
Tianjin
The Second Affiliated Hospital of Wenzhou Medical University
NOT_YET_RECRUITING
Wenzhou
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
NOT_YET_RECRUITING
Wuhan
Wuhan Asia Heart Hospital
NOT_YET_RECRUITING
Wuhan
The First Affiliated Hospital of Xi'an Jiaotong University
NOT_YET_RECRUITING
Xi'an
People's Hospital of Xinjiang Uygur Autonomous Region
NOT_YET_RECRUITING
Xinjiang
The First Affiliated Hospital of Xinjiang Medical University
NOT_YET_RECRUITING
Xinjiang
Yantai Yuhuangding Hospital
NOT_YET_RECRUITING
Yantai
Fuwai Huazhong Cardiovascular Hospital
NOT_YET_RECRUITING
Zhengzhou
The First Affiliated Hospital of Zhengzhou University
NOT_YET_RECRUITING
Zhengzhou
Zunyi Medical University Affiliated Hospital
NOT_YET_RECRUITING
Zunyi
Contact Information
Primary
Jingbo Hou, Ph.D.
jingbohou@163.com
13303609625
Backup
Bo Yu, Ph.D.
yubodr@163.com
Time Frame
Start Date: 2026-07-13
Estimated Completion Date: 2030-12
Participants
Target number of participants: 2000
Treatments
Experimental: Guideline-recommended standard medical therapy alone
Dual antiplatelet therapy, anticoagulation, thrombolysis, lipid-lowering, and other guideline recommended drugs related to myocardial infarction.
Active_comparator: 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.
Related Therapeutic Areas
Sponsors
Leads: Harbin Medical University

This content was sourced from clinicaltrials.gov

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