Heart Bypass Surgery Clinical Trials

Clinical trials related to Heart Bypass Surgery Procedure

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

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

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

• . 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.

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: 2032-01-01
Participants
Target number of participants: 1244
Treatments
Experimental: DCB group
STEMI patients undergo revascularization using DCB
Active_comparator: DES group
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