Actively Recruiting
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
Eligibility Criteria
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
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
Trial Site Locations
Total: 1 location
1
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China
Actively Recruiting
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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