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NCT Number: NCT07436429

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

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.

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Key information

Conditions

Myocardial Infarction (MI) Acute Coronary Syndrome Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI) Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms ST Elevation Myocardial Infarction ST-elevation Myocardial Infarction STEMI STEMI (STE-ACS) Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All ST-elevation MI undergoing Primary PCI

Exclusion criteria

  • In-stent culprit lesion
  • Contraindications to antiplatelets
  • Stent implantation within 3 months before enrollment
  • Cardiac arrest, intubation, or cardiogenic shock
  • Life-expectancy less than one year

Treatment and study plan

Drug-coated Balloon

Device

Provisional DCB-based pPCI for a de novo coronary

Other names: Drug-Eluting Balloon, DCB, DEB

Primary outcomes

  1. Net adverse clinical events (NACE)

    Time frame: From January 2014 to April 2026

    Composite of :Device success, Procedural success, Angiographic success diameter stenosis <40% by visual estimation and TIMI flow grade ≥2, Target vessel dissection ≥ type C, Bailout stenting

Secondary outcomes

  1. Individual NACE components

    Time frame: Jenuary 2014 to April 2026

  2. Any Bleeding

    Time frame: January 2014- April 2026

    Any bleeding classified according to the Bleeding Academic Research Consortium (BARC) criteria.

  3. Target Vessel Failure (TVF)

    Time frame: January 2014-April 2026

    Composite of cardiovascular death, target vessel myocardial infarction, or target vessel revascularization, according to Academic Research Consortium drug-coated balloon consensus definitions.

Study contacts

Contact information is provided by the study sponsor or research team.

Riccardo Terzi, MD, BSc

CONTACT

[email protected]

+393312127467

Sponsors and collaborators

Lead sponsor

Medical University of Vienna

Other

Registry information

Official study title

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

Acronym: DCB-STEMI

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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