Drug-Coated Balloon Primary PCI in ST-Segment Elevation Myocardial Infarction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Drug-Coated Balloon.
- Who it may be relevant to
- Registry conditions: Myocardial Infarction (MI), ST-Elevation Myocardial Infarction, STEMI, STEMI (STE-ACS). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Austria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Drug Coated Balloon-Based Primary PCI in ST-segment Elevation Myocardial Infarction - The DCB-STEMI Multicenter Registry
Overview
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.
Interventions
- Device Drug-Coated Balloon
Provisional DCB-based pPCI for a de novo coronary
Primary outcome measures
- Net adverse clinical events (NACE) [Time frame: From January 2014 to April 2026]
Secondary outcome measures (3)
- Individual NACE components [Time frame: Jenuary 2014 to April 2026]
- Any Bleeding [Time frame: January 2014- April 2026]
- Target Vessel Failure (TVF) [Time frame: January 2014-April 2026]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Austria · 1 center
- Universitatsklinikum AKH wien — Vienna
Identifiers
NCT: NCT07436429 · 1535/2023