Drug-Coated Balloon Versus Drug-Eluting Stent in Heart Attack Patients
Compares a drug-coated balloon with a drug-eluting stent in adults having a heart attack.
Plain-language title generated from the registry record
Registry title: Drug-Eluting Balloon or Drug-Eluting Stent in Acute Myocardial Infarction: A Randomized Controlled Trial
Key facts
- Where
- Belgrade, Kamenitz, Kragujevac, and Niš, SerbiaSee the 4 sites
Where in Serbia
- University Clinical Center of SerbiaBelgrade, SerbiaTaking people
- Institute of Cardiovascular Diseases of VojvodinaKamenitz, SerbiaTaking people
- University Clinical Center of KragujevacKragujevac, SerbiaNot yet recruiting
- University Clinical Centre of NisNiš, SerbiaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Institute of Cardiovascular Diseases, Vojvodina
- Trial code
- NCT06746233
- Record updated
- 30 March 2026
- Original description
The objective of the study is to compare drug-coated balloon (DCB) with the gold standard drug-eluting stent (DES) in percutaneous coronary intervention (PCI) for patients presenting with ST-elevation myocardial infarction (STEMI).Read full original descriptionShow less
A Prospective, Randomized, Multicenter, International, Open-Label Clinical Trial Comparing Drug-Coated Balloon and Drug-Eluting Stent for the Treatment of Acute ST-Elevation Myocardial Infarction.
The objective of the study is to compare drug-coated balloon (DCB) with the gold standard drug-eluting stent (DES) in percutaneous coronary intervention (PCI) for patients presenting with ST-elevation myocardial infarction (STEMI).
Randomization will be performed after successful culprit-lesion preparation and confirmation that all angiographic entry criteria are met. Patients will be randomly assigned in a 1:1 fashion to receive either treatment with a Paclitaxel-coated balloon alone or second or third-generation DES.
Inclusion: Age >18 years with a life expectancy of >1 year; Patients fulfilling criteria for STEMI (>20 min of chest-pain; At least 1 mm ST-elevation in at least two contiguous leads, a new left bundle branch block or a true posterior myocardial infarction confirmed by ECG or echocardiography; Reperfusion is expected to be feasible within 12 h after onset of symptoms); Infarct related artery eligible for primary PCI (De novo lesion in a native coronary artery; Reference-vessel diameter ≥2.5 mm and ≤ 4 mm; Absence of severe calcification; Residual diameter stenosis of ≤30% (by visual assessment) after lesion preparation after lesion preparation; Absence of coronary dissection type ≥C.
Exclusion: Known contraindication for aspirin, clopidogrel, ticagrelor, heparin or GP IIb/IIIa inhibitor; Previous myocardial infarction; Previous PCI in the territory of the infarct-related artery (IRA); Previous CABG; 3-vessel disease requiring revascularization; Left-main disease; History of ischemic stroke within the past 6 months or hemorrhagic stroke; Killip class>II on admission; Extremely angulated or severely calcified vessels; Planned CABG for a non-culprit vessel; Participation in another investigational trial that has not completed its primary endpoint or could interfere with the endpoints of this study.