NCT06746233Recruiting
Drug-Eluting Balloon or Drug-Eluting Stent in Acute Myocardial Infarction: A Randomized Controlled Trial
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.
Source: ClinicalTrials.gov · Last updated 30 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 598 (estimated)
- First submitted
- 13 Dec 2024
- Start date
- 25 Dec 2024
- Primary completion date
- Dec 2028
- Lead sponsor
- Institute of Cardiovascular Diseases, Vojvodina
- Diseases
- Coronary artery disease
- NCT number
- NCT06746233
What you commit to
- Study type: Interventional
- Planned participants: 598
- From 25 Dec 2024 to the primary completion date, Dec 2028
- 5 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
Other illness
- 3-vessel disease requiring revascularization
- Left-main disease
- History of ischemic stroke within the past 6 months or hemorrhagic stroke
Other
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Clinical Center of Serbia Coordinator of this site? Confirm its status | Belgrade | Serbia | Recruiting |
| Institute of Cardiovascular Diseases of Vojvodina Coordinator of this site? Confirm its status | Kamenitz | Serbia | Recruiting |
| University Clinical Center of Kragujevac Coordinator of this site? Confirm its status | Kragujevac | Serbia | Not yet recruiting |
| University Clinical Centre of Nis Coordinator of this site? Confirm its status | Niš | Serbia | Not yet recruiting |
| University Clinical Centre of the Republic of Srpska Coordinator of this site? Confirm its status | Banja Luka | Bosnia and Herzegovina | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.