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Drug-Eluting Balloon or Drug-Eluting Stent in Acute Myocardial Infarction: A Randomized Controlled Trial

RecruitingNAAges 18 Years - anyAllInstitute of Cardiovascular Diseases, Vojvodina
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Drug (paclitaxel) coated balloon (DCB)
  • Second-generation Drug Eluting Stent (DES)
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Where

5 sites
University Clinical Centre of the Republic of Srpska
Banja Luka, Bosnia and Herzegovina
University Clinical Centre of Nis
Niš, Serbia
University Clinical Center of Serbia
Belgrade, Serbia
Institute of Cardiovascular Diseases of Vojvodina
Kamenitz, Serbia
University Clinical Center of Kragujevac
Kragujevac, Serbia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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