Acute Coronary Syndrome (ACS) Undergoing Percutaneous Coronary Intervention (PCI), Myocardial Infarction (MI), ST-Elevation Myocardial Infarction, STEMI, STEMI (STE-ACS)
Conditions
Keywords
Drug-coated balloon, Primary percutaneous coronary intervention, De novo coronary lesion, Limus-coated balloon, Paclitaxel-coated balloon, Net adverse clinical events, Bleeding Academic Research Consortium bleeding, ST-segment elevation myocardial infarction, Drug-Eluting Balloon
Brief 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.
Interventions
DEVICEDrug-Coated Balloon
Provisional DCB-based pPCI for a de novo coronary
Sponsors
Medical University of Vienna
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Net adverse clinical events (NACE) | 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
| Measure | Time frame | Description |
|---|---|---|
| Individual NACE components | Jenuary 2014 to April 2026 | — |
| Any Bleeding | January 2014- April 2026 | Any bleeding classified according to the Bleeding Academic Research Consortium (BARC) criteria. |
| Target Vessel Failure (TVF) | 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. |
Countries
Austria
Contacts
CONTACTRiccardo Terzi, MD, BSc
PRINCIPAL_INVESTIGATORRayyan Hemetsberger, MD
Universitatsklinikum AKH wien
PRINCIPAL_INVESTIGATORMohammad Abdelghani, MD, PhD
Sohar Hospital, Sohar, Oman
Outcome results
None listed