Actively Recruiting
Drug-Eluting Balloon or Drug-Eluting Stent in Acute Myocardial Infarction: A Randomized Controlled Trial
Led by Institute of Cardiovascular Diseases, Vojvodina · Updated on 2026-03-30
598
Participants Needed
5
Research Sites
205 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Drug-Eluting Balloon or Drug-Eluting Stent in Acute Myocardial Infarction: A Randomized Controlled Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age >18 years with a life expectancy of >1 year
- Diagnosis of STEMI with chest pain lasting more than 20 minutes
- At least 1 mm ST-elevation in at least two contiguous leads, new left bundle branch block, or confirmed true posterior myocardial infarction
- Reperfusion feasible within 12 hours after symptom onset
- Infarct-related artery suitable for PCI with de novo lesion in native coronary artery
- Reference vessel diameter between 2.5 mm and 4 mm
- Absence of severe artery calcification
- Residual diameter stenosis ≤30% after lesion preparation
- No coronary dissection type ≥C after lesion preparation
You will not qualify if you...
- Killip class > II on admission
- Known allergy or contraindication to aspirin, clopidogrel, ticagrelor, heparin, or GP IIb/IIIa inhibitors
- Previous myocardial infarction
- Previous PCI in the infarct-related artery
- Previous coronary artery bypass graft (CABG)
- Presence of three-vessel disease requiring revascularization
- Left-main coronary artery disease
- Extremely angulated or severely calcified vessels
- History of ischemic or hemorrhagic stroke within the last 6 months
- Planned CABG for a non-culprit vessel
- Participation in another investigational trial that might interfere with this study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
University Clinical Centre of the Republic of Srpska
Banja Luka, Bosnia and Herzegovina, 21204
Actively Recruiting
2
University Clinical Centre of Nis
Niš, Serbia, Serbia, 18105
Not Yet Recruiting
3
University Clinical Center of Serbia
Belgrade, Serbia, 11000
Actively Recruiting
4
Institute of Cardiovascular Diseases of Vojvodina
Kamenitz, Serbia, 21204
Actively Recruiting
5
University Clinical Center of Kragujevac
Kragujevac, Serbia, 34000
Not Yet Recruiting
Research Team
M
Mila Kovačević, MD, PhD
CONTACT
B
Branislav Crnomarković, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here