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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The incidence of premature coronary artery disease (PCAD) is on the rise, and there is a critical need to improve long-term outcomes. Drug-coated balloon (DCB) represent a promising treatment option for patients with PCAD. However, high-quality clinical data on the impact of DCB on the long-term prognosis of myocardial infarction patients are lacking. This study aims to compare the 12-month clinical outcomes, including all-cause mortality, non-fatal myocardial infarction, and any revascularization, of DCB versus drug-eluting stent (DES) in patients with premature ST-segment elevation myocardial infarction (STEMI). The objective is to verify the efficacy and safety of the DCB implant-free regimen in these patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• . Age of Patients ≥18 years old; Male ≤ 55 years old/female ≤ 65 years old were diagnosed as coronary atherosclerotic heart disease;

• 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.

Locations
Other Locations
China
Second Affiliated Hospital, School of Medicine, Zhejiang University
RECRUITING
Hangzhou
Contact Information
Primary
Jucheng Zhang
jucheng@zju.edu.cn
+8618768146640
Time Frame
Start Date: 2025-05-31
Estimated Completion Date: 2028-01-01
Participants
Target number of participants: 1244
Treatments
Experimental: DCB group
premature STEMI patients undergo revascularization using DCB
Active_comparator: DES group
premature STEMI patients undergo revascularization using DES
Sponsors
Leads: Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators: The First Affiliated Hospital of Zhengzhou University, Peking University First Hospital, First Affiliated Hospital of Ningbo University, Suzhou Municipal Hospital

This content was sourced from clinicaltrials.gov