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RecruitingNCT06742125DCB-STEMIUpdated Sep 28, 2026

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

An interventional study of Drug-coated balloon (DCB) and Drug-eluting stent (DES) in ST-elevation Myocardial Infarction (STEMI), sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
1,244
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Objectives of Study:

Compare the clinical outcomes of drug-coated balloon (DCB) and drug-eluting stent (DES) treatment in patients with ST-segment elevation myocardial infarction (STEMI).

Design of Study:

Investigator-Initiated，Open Label，Prospective，Multicenter，Randomized Clinical Trial.

Patients Selected： This study aims to STEMI patients who have successfully completed lesion pretreatment in multiple medical centers in China. Patients who meet the inclusion criteria and have no exclusion criteria will be randomly assigned 1:1 to the drug coated balloon group and drug eluting stent group, totaling 1244 cases (622 cases per group).

02

Conditions studied

  • ST-elevation Myocardial Infarction (STEMI)

Keywords

  • Drug-coated balloon
  • Drug-eluting stent
  • ST-elevation myocardial infarction (STEMI)
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,244 participants (estimated)

Study arms

  • Experimental
    DCB group

    STEMI patients undergo revascularization using DCB

    Device: Drug-coated balloon (DCB)

  • Active comparator
    DES group

    STEMI patients undergo revascularization using DES

    Device: Drug-eluting stent (DES)

Interventions

  • DeviceDrug-coated balloon (DCB)

    Drug-coated balloon treatment of target lesions in patients with STEMI undergoing percutaneous coronary intervention.

  • DeviceDrug-eluting stent (DES)

    Drug-eluting stent treatment of target lesions in patients with STEMI undergoing percutaneous coronary intervention.

05

What researchers measure

Primary outcomes

  1. Incidence of patient-oriented composite endpoints (POCE) (Direct measurement and coronary angiography)

    POCE including all-cause mortality, any stroke, any myocardial infarction (MI), and any revascularization, will be obtained through follow-up of subjects.

    Time frame: 12 months

Secondary outcomes

  1. Incidence of patient-oriented composite endpoints (POCE) (Direct measurement and coronary angiography)

    POCE including all-cause mortality, any stroke, any myocardial infarction (MI), and any revascularization, will be obtained through follow-up of subjects.

    Time frame: 36 months, 60 months

  2. Incidence of target vessel failure (Direct measurement and coronary angiography)

    Target vessel failure (a composite of cardiac death, target-vessel MI, or target vessel revascularization) will be obtained through follow-up of subjects.

    Time frame: 12 months

  3. Incidence of all-cause mortality (Direct measurement)

    All-cause mortality will be obtained through follow-up of subjects.

    Time frame: 36 months, 60 months

  4. Incidence of non-fatal MI (Direct measurement)

    Non-fatal MI will be obtained through follow-up of subjects.

    Time frame: 36 months, 60 months

  5. Incidence of any revascularization (coronary angiography)

    Any revascularization will be obtained through follow-up of subjects.

    Time frame: 36 months, 60 months

  6. Incidence of all-cause and cardiac death (Direct measurement)

    All-cause and cardiac death will be obtained through follow-up of subjects.

    Time frame: 12 months, 36 months, 60 months

  7. Incidence of any non-fatal MI without peri-procedural MI (Direct measurement)

    Any non-fatal MI without peri-procedural MI will be obtained through follow-up of subjects.

    Time frame: 12 months, 36 months, 60 months

  8. Incidence of any non-fatal MI with peri-procedural MI (Direct measurement)

    Any non-fatal MI with peri-procedural MI will be obtained through follow-up of subjects.

    Time frame: 12 months, 36 months, 60 months

  9. Incidence of any target vessel/lesion revascularization (Coronary angiography)

    Any target vessel/lesion revascularization will be obtained through follow-up of subjects.

    Time frame: 12 months, 36 months, 60 months

  10. Incidence of any non-target vessel/lesion revascularization (Coronary angiography)

    Any non-target vessel/lesion revascularization will be obtained through follow-up of subjects.

    Time frame: 12 months, 36 months, 60 months

  11. Incidence of any revascularization (ischemia-driven or all) (Coronary angiography)

    Any revascularization (ischemia-driven or all) will be obtained through follow-up of subjects.

    Time frame: 12 months, 36 months, 60 months

  12. Incidence of non-fatal stroke (ischemic and hemorrhagic) (Direct measurement)

    Non-fatal stroke (ischemic and hemorrhagic) will be obtained through follow-up of subjects.

    Time frame: 12 months, 36 months, 60 months

  13. CRP and POCE

    Prognostic value of CRP on POCE

    Time frame: 12 months, 36 months, 60 months

06

Study locations

1 of 1 sites recruiting
  • Second Affiliated Hospital, School of Medicine, Zhejiang University
    Hangzhou, Zhejiang, China
    Recruiting
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06742125
Lead sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Collaborators
The First Affiliated Hospital of Zhengzhou University, Peking University First Hospital, Suzhou Municipal Hospital, First Affiliated Hospital of Ningbo University
Responsible party
Sponsor
First posted
Dec 19, 2024
Start date
May 31, 2025
Primary completion
Jan 1, 2032 (estimated)
Completion
Jan 1, 2032 (estimated)
Last update
Sep 28, 2026

Study contacts

Jucheng Zhang
Contact
jucheng@zju.edu.cn
+8618768146640
Jun Jiang
study director · Second Affiliated Hospital, Zhejiang University, School of Medicine

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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