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

NCT06742125 | Recruiting DMC

• 1 other identifier: 2024-0936
• Study Type: interventional
• Target: 1,244
• Locations: 1 country
• Sites: 1

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.

Conditions

ST-elevation Myocardial Infarction (STEMI)

Keywords

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

Outcome Measures

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.

  12 months

Secondary Outcomes (13)

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

  36 months, 60 months

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

  12 months

• Incidence of all-cause mortality (Direct measurement)

  36 months, 60 months

• Incidence of non-fatal MI (Direct measurement)

  36 months, 60 months

• Incidence of any revascularization (coronary angiography)

  36 months, 60 months

Study Arms (2)

DCB group

EXPERIMENTAL

STEMI patients undergo revascularization using DCB

Device: Drug-coated balloon (DCB)

DES group

ACTIVE COMPARATOR

STEMI patients undergo revascularization using DES

Device: Drug-eluting stent (DES)

Interventions

Drug-coated balloon (DCB) DEVICE

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

DCB group

Drug-eluting stent (DES) DEVICE

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

DES group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of Patients ≥18 years old;
• Acute myocardial infarction patients with onset symptoms\<48 hours require emergency PCI;
• 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;
• Criminal blood vessels with clear requirements for emergency PCI;
• Coronary artery in situ lesions, with a visual reference lumen diameter of ≥ 2mm and ≤ 4mm; Lesion's length\<40mm；
• After thrombus aspiration and pre dilation, the lesion stenosis is ≤ 50% and there is no C-type or above dissection.
• He/she or his/her legal representative voluntarily participates in this study and signs an informed consent form.

You may not qualify if:

• 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);
• The patient has active pathological bleeding;
• History of significant gastrointestinal or urogenital bleeding or bleeding tendency within 3 months prior to surgery, known coagulation disorders (including heparin induced thrombocytopenia);
• Patients who are pregnant or have the intention to become pregnant during the period of research;
• Non cardiogenic combined lesions show an expected life expectancy of less than one year;
• Left main trunk's stenosis ≥ 50%
• History of coronary artery bypass grafting in the past;
• Intubation or mechanical ventilation status;
• Cardiogenic Shock
• Without signature on informed consent

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead
• The First Affiliated Hospital of Zhengzhou University: collaborator
• Peking University First Hospital: collaborator
• Suzhou Municipal Hospital: collaborator
• First Affiliated Hospital of Ningbo University: collaborator

Study Sites (1)

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Study Officials

• Jun Jiang

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  STUDY DIRECTOR

Central Study Contacts

Jucheng Zhang

CONTACT

+8618768146640; jucheng@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 9, 2024
• First Posted: December 19, 2024
• Study Start: May 31, 2025
• Primary Completion (Estimated): January 1, 2032
• Study Completion (Estimated): January 1, 2032
• Last Updated: January 29, 2026

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)