Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06742125

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

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-01-29

1244

Participants Needed

1

Research Sites

343 weeks

Total Duration

On this page

Sponsors

S

Second Affiliated Hospital, School of Medicine, Zhejiang University

Lead Sponsor

T

The First Affiliated Hospital of Zhengzhou University

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 18 years or older
  • Acute myocardial infarction patients with symptoms starting less than 48 hours ago requiring emergency PCI
  • Diagnosis includes chest pain with ST-segment elevation in at least two adjacent ECG leads or new left bundle branch block
  • Target coronary artery lesions with reference lumen diameter between 2 mm and 4 mm and lesion length less than 40 mm
  • After thrombus aspiration and pre-dilation, lesion stenosis is 50% or less with no severe dissection
  • Voluntary participation with signed informed consent
Not Eligible

You will not qualify if you...

  • Allergies or contraindications to Heparin, Aspirin, Clopidogrel, Prasugrel, Ticagrelor, Cilostazol, Indobufen, or contrast media (unless controlled with medication)
  • 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
  • Pregnant or planning pregnancy during the study period
  • Non-cardiogenic lesions with life expectancy less than one year
  • Left main coronary artery stenosis of 50% or more
  • History of coronary artery bypass grafting
  • Intubation or mechanical ventilation
  • Cardiogenic shock
  • Lack of signed informed consent

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Actively Recruiting

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Research Team

J

Jucheng Zhang

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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