NCT07436429

Drug-Coated Balloon Primary PCI in ST-Segment Elevation Myocardial Infarction

Drug Coated Balloon-Based Primary PCI in ST-segment Elevation Myocardial Infarction - The DCB-STEMI Multicenter Registry

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 300 (estimated)
• Sponsor: Medical University of Vienna · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Drug-eluting stent (DES)-based primary percutaneous intervention (pPCI) has been established as the standard of care for patients presenting with ST-segment elevation myocardial infarction (STEMI), having demonstrated superiority over thrombolysis, plain balloon angioplasty, and bare-metal stents. Recently, the use of drug-coated balloons (DCB) has expanded dramatically across a variety of anatomical and clinical settings, including de novo coronary lesions. A DCB-based pPCI strategy may simplify the procedure and mitigate the risks of inadequate stent sizing due to spasm or large thrombus burden, acute stent thrombosis, distal embolization, no reflow, and the relatively higher incidence of late stent-related adverse events compared with elective PCI. Despite these theoretical advantages, data on the safety and efficacy of DCB-based pPCI in STEMI remains limited. The aim of this registry is to explore procedural and clinical outcomes of patients with STEMI treated with a DCB-based pPCI strategy.

Conditions

• Myocardial Infarction (MI)
• ST-Elevation Myocardial Infarction
• STEMI
• STEMI (STE-ACS)
• Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI)

Interventions

Type	Name	Description
DEVICE	Drug-Coated Balloon	Provisional DCB-based pPCI for a de novo coronary

Timeline

• Start date: 2026-02-08
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: Austria