RECRUITINGINTERVENTIONAL

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.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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 Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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

Treatments Being Tested

DEVICE

Drug (paclitaxel) coated balloon (DCB)

In the experimental arm, a paclitaxel-coated balloon (DCB) delivering 3.0-3.5 µg/mm² will be used in STEMI patients after successful lesion preparation (defined as residual stenosis ≤30%, TIMI flow grade 2-3, and absence of flow-limiting dissection). If the result after DCB treatment is unsatisfactory, bailout implantation of a drug-eluting stent (DES) will be performed at the operator's discretion.

DEVICE

Second-generation Drug Eluting Stent (DES)

In the control arm, patients randomized to the DES treatment group will undergo implantation of a second-generation drug-eluting stent (DES) using standard techniques, according to current practice guidelines

Locations (5)

University Clinical Centre of the Republic of Srpska

Banja Luka, Bosnia and Herzegovina

University Clinical Centre of Nis

Niš, Serbia, Serbia

University Clinical Center of Serbia

Belgrade, Serbia

Institute of Cardiovascular Diseases of Vojvodina

Kamenitz, Serbia

University Clinical Center of Kragujevac

Kragujevac, Serbia