NCT06742125 Drug-Coated Balloon Versus Drug-Eluting Stent in Patient With ST-Segment Elevation Myocardial Infarction

Eligibility & Interventions

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This trial targets 1,244 participants in total. It began in 2025-05-31 with a primary completion date of 2032-01-01.

Brief Summary

Acute ST-segment elevation myocardial infarction (STEMI) is a life-threatening emergency requiring immediate intervention. The incidence of premature coronary artery disease (PCAD) is rising rapidly in China; its long-term prognosis remains poor and it frequently progresses to acute myocardial infarction, necessitating high-risk therapies such as primary percutaneous coronary intervention (PCI) or coronary artery bypass grafting, thereby imposing enormous economic and psychological burdens on patients and their families. Moreover, the cumulative 6-year rate of death or myocardial infarction after implantation of the latest-generation drug-eluting stents still reaches 15%, and management of stent failure is extremely challenging. Drug-coated balloon (DCB) angioplasty-representing the "leave-nothing-behind" paradigm-is a highly promising option in young subjects. Accumulating clinical evidence demonstrates that DCB provides favorable efficacy across a broad spectrum of lesions, including small-vessel and large-vessel de novo disease, bifurcation lesions, and in-stent restenosis. Nevertheless, high-quality data on the impact of DCB angioplasty in de novo large-vessel disease and in the setting of acute STEMI are still lacking.

Eligibility Criteria

Inclusion Criteria: 1. . Age of Patients ≥18 years old; 2. Acute myocardial infarction patients with onset symptoms\<48 hours require emergency PCI; 3. . Diagnosis: Chest pain and other ischemic symptoms accompanied by ST segment elevation in at least two adjacent leads on electrocardiogram (① V2 or V3 lead: male\<40 years ≥ 0.25mV, ≥ 40 years ≥ 0.2mV; Female ≥1.5mV；② Other leads ≥ 1mV), or new left bundle branch block occurs; 4. Criminal blood vessels with clear requirements for emergency PCI; 5. Coronary artery in situ lesions, with a visual reference lumen diameter of ≥ 2mm and ≤ 4mm; Lesion's length\<40mm； 6. After thrombus aspiration and pre dilation, the lesion stenosis is ≤ 50% and there is no C-type or above dissection. 7. He/she or his/her legal representative voluntarily participates in this study and signs an informed consent form. Exclusion Criteria: 1. The patient has allergies or contraindications to the following medications: Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Cilostazol, Indobufen, Contrast Medias (Patients with clear contrast agent allergies such as rash but can be controlled with effective drugs such as glucocorticoids and diphenhydramine in advance can be selected); 2. The patient has active pathological bleeding; 3. History of significant gastrointestinal or urogenital bleeding or bleeding tendency within 3 months prior to surgery, known coagulation disorders (including heparin induced thrombocytopenia); 4. Patients who are pregnant or have the intention to become pregnant during the period of research; 5. Non cardiogenic combined lesions show an expected life expectancy of less than one year; 6. Left main trunk's stenosis ≥ 50% 7. History of coronary artery bypass grafting in the past; 8. Intubation or mechanical ventilation status; 9. . Cardiogenic Shock 10. . Without signature on informed consent

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