Phase
Condition
Myocardial Ischemia
Heart Defect
Coronary Artery Disease
Treatment
Second-generation Drug Eluting Stent (DES)
Drug (paclitaxel) coated balloon (DCB)
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 mmST-elevation in at least two contiguous leads, a new left bundle branch block or atrue 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 coronaryartery; Reference-vessel diameter ≥2.5 mm and ≤ 4 mm; Absence of severecalcification; Residual diameter stenosis of ≤30% (by visual assessment) afterlesion preparation after lesion preparation; Absence of coronary dissection type ≥C.
Exclusion
Exclusion Criteria:
Killip class>II on admission
Known contraindication for aspirin, clopidogrel, ticagrelor, heparin or GP IIb/IIIainhibitor
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 primaryendpoint or could interfere with the endpoints of this study
Study Design
Connect with a study center
University Clinical Center of Serbia
Belgrade, 11000
SerbiaActive - Recruiting
University Clinical Center of Kragujevac
Kragujevac, 34000
SerbiaSite Not Available
University Clinical Centre of Nis
Nis, 18105
SerbiaSite Not Available
University Clinical Centre of Nis
Niš, 18105
SerbiaSite Not Available
Institute of Cardiovascular Diseases of Vojvodina
Sremska Kamenica, 21204
SerbiaActive - Recruiting
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