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

NCT07436429 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2026-02-27

No results posted yet for this study

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

DEVICE

Drug-Coated Balloon

Provisional DCB-based pPCI for a de novo coronary

Sponsors & Collaborators

  • Medical University of Vienna

    lead OTHER

Principal Investigators

  • Rayyan Hemetsberger, MD · Universitatsklinikum AKH wien

  • Mohammad Abdelghani, MD, PhD · Sohar Hospital, Sohar, Oman

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-08
Primary Completion
2026-07-31
Completion
2026-07-01

Countries

  • Austria

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07436429 on ClinicalTrials.gov