NCT06746233 Drug-Eluting Balloon or Drug-Eluting Stent in Acute Myocardial Infarction: A Randomized Controlled Trial
| NCT ID | NCT06746233 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Institute of Cardiovascular Diseases, Vojvodina |
| Condition | ST Elevation Myocardial Infarction (STEMI) |
| Study Type | INTERVENTIONAL |
| Enrollment | 598 participants |
| Start Date | 2024-12-25 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 598 participants in total. It began in 2024-12-25 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Criteria: * Killip class\>II on admission * 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 * Extremely angulated or severely calcified vessels * History of ischemic stroke within the past 6 months or hemorrhagic stroke * 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
Contact & Investigator
Mila Kovačević, MD, PhD
PRINCIPAL INVESTIGATOR
Institute of Cardiovascular Diseases of Vojvodina
Frequently Asked Questions
Who can join the NCT06746233 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying ST Elevation Myocardial Infarction (STEMI). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06746233 currently recruiting?
Yes, NCT06746233 is actively recruiting participants. Contact the research team at milakov979@gmail.com for enrollment information.
Where is the NCT06746233 trial being conducted?
This trial is being conducted at Banja Luka, Bosnia and Herzegovina, Niš, Serbia, Belgrade, Serbia, Kamenitz, Serbia and 1 additional location.
Who is sponsoring the NCT06746233 clinical trial?
NCT06746233 is sponsored by Institute of Cardiovascular Diseases, Vojvodina. The principal investigator is Mila Kovačević, MD, PhD at Institute of Cardiovascular Diseases of Vojvodina. The trial plans to enroll 598 participants.