Drug-coated balloon versus drug-eluting stent for treating STEMI

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an investigator-initiated, open-label, prospective, multicenter randomized non-inferiority trial in China that will randomize 1,244 STEMI patients 1:1 to drug-coated balloon (DCB) or drug-eluting stent (DES) after successful lesion pretreatment. The primary endpoint is a 12-month patient-oriented composite endpoint (POCE) including all-cause death, any myocardial infarction, any stroke, and any revascularization, with follow-up conducted over the study's 2-year participation window. The trial uses a non-inferiority margin of 2.5% with a planned 80% power and Kaplan–Meier survival analysis for event comparison. Enrollment is limited to eligible adults treated at participating tertiary centers with target vessel diameter 2–4 mm and lesion length <40 mm.

Why it matters

Who can join: the full rules

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

Where it's running

• Second Affiliated Hospital, School of Medicine, Zhejiang University
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Jucheng Zhang
• Email: jucheng@zju.edu.cn
• Phone: +8618768146640

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.