[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573434":3},{"organization":4,"outcomesModule":7,"designInfo":28,"detailedDescription":22,"studyPopulation":22,"armGroups":34,"interventions":47,"overallOfficials":57,"centralContacts":62,"locations":71,"responsibleParty":153,"collaborators":22,"id":157,"slug":158,"hasResults":159,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":159,"sex":165,"minAge":166,"maxAge":22,"enrollmentInfo":167,"targetDuration":22,"studyType":170,"phases":171,"briefSummary":173,"conditions":174,"keywords":176,"overallStatus":74,"whyStopped":22,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":189},{"fullName":5,"class":6},"Institute of Cardiovascular Diseases, Vojvodina","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":22},[9],{"measure":10,"description":11,"timeFrame":12},"DoCE (Device-oriented composite endpoint)","DoCE: A composite endpoint consisting of cardiac mortality, non-fatal target vessel myocardial infarction (NF-TVMI), and target lesion revascularization (TLR).","1 year and 2 years",[14,17,20,23,26],{"measure":15,"description":16,"timeFrame":12},"Individual components of the primary endpoint (DoCE)","Individual components of the primary endpoint (DoCE):\n\n* Cardiac mortality\n* Non-fatal target vessel myocardial infarction (NF-TVMI)\n* Target lesion revascularization (TLR)",{"measure":18,"description":19,"timeFrame":12},"Patient-oriented composite endpoint (PoCE)","PoCE: Defined as a composite of all-cause death, any stroke, any myocardial infarction (MI), and any clinically or physiologically indicated revascularization.",{"measure":21,"description":22,"timeFrame":12},"Target vessel revascularization (TVR)",null,{"measure":24,"description":25,"timeFrame":12},"Target vessel failure (TVF)","Target Vessel Failure (TVF): Defined as a composite of cardiac death, target vessel myocardial infarction (MI), and clinically or physiologically indicated target vessel revascularization (TVR).",{"measure":27,"description":22,"timeFrame":12},"BARC (Bleeding Academic Research Consortium) type 3 and 5 bleeding complications.",{"allocation":29,"interventionModel":30,"interventionModelDescription":22,"primaryPurpose":31,"observationalModel":22,"timePerspective":22,"maskingInfo":32},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":33,"maskingDescription":22,"whoMasked":22},"NONE",[35,41],{"label":36,"type":37,"description":38,"interventionNames":39},"Drug coated balloon (DCB)","EXPERIMENTAL","Drug (paclitaxel) coated balloon (DCB) with concentration of 3-3.5 μg Paclitaxel per 1 mm2",[40],"Device: Drug (paclitaxel) coated balloon (DCB)",{"label":42,"type":43,"description":44,"interventionNames":45},"Second generation of drug eluting stents (DES)","ACTIVE_COMPARATOR","Drug eluting stent (DES)",[46],"Device: Second-generation Drug Eluting Stent (DES)",[48,53],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":22},"DEVICE","Drug (paclitaxel) coated balloon (DCB)","In the experimental arm, a paclitaxel-coated balloon (DCB) delivering 3.0-3.5 µg\u002Fmm² 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.",[36],{"type":49,"name":54,"description":55,"armGroupLabels":56,"otherNames":22},"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",[42],[58],{"name":59,"affiliation":60,"role":61},"Mila Kovačević, MD, PhD","Institute of Cardiovascular Diseases of Vojvodina","PRINCIPAL_INVESTIGATOR",[63,67],{"name":59,"role":64,"phone":65,"phoneExt":22,"email":66},"CONTACT","+381601594444","milakov979@gmail.com",{"name":68,"role":64,"phone":69,"phoneExt":22,"email":70},"Branislav Crnomarković, MD","+381642636495","branislavc.89@gmail.com",[72,91,109,124,138],{"facility":73,"status":74,"city":75,"state":22,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"University Clinical Centre of the Republic of Srpska","RECRUITING","Banja Luka","21204","Bosnia and Herzegovina","BA",{"type":80,"coordinates":81},"Point",[82,83],17.20629,44.77879,{"lat":83,"lon":82},[86,90],{"name":87,"role":64,"phone":88,"phoneExt":22,"email":89},"Bojan Stanetić, MD, PhD","+38765614340","bojan.stanetic@gmail.com",{"name":87,"role":61,"phone":22,"phoneExt":22,"email":22},{"facility":92,"status":93,"city":94,"state":95,"zip":96,"country":95,"countryCode":97,"cosmosGeoPoint":98,"geoPoint":102,"contacts":103},"University Clinical Centre of Nis","NOT_YET_RECRUITING","Niš","Serbia","18105","RS",{"type":80,"coordinates":99},[100,101],21.90333,43.32472,{"lat":101,"lon":100},[104,108],{"name":105,"role":64,"phone":106,"phoneExt":22,"email":107},"Bojan Maričić, MD, PhD","+381692918755","bokimaricic@gmail.com",{"name":105,"role":61,"phone":22,"phoneExt":22,"email":22},{"facility":110,"status":74,"city":111,"state":22,"zip":112,"country":95,"countryCode":97,"cosmosGeoPoint":113,"geoPoint":117,"contacts":118},"University Clinical Center of Serbia","Belgrade","11000",{"type":80,"coordinates":114},[115,116],20.46513,44.80401,{"lat":116,"lon":115},[119,123],{"name":120,"role":64,"phone":121,"phoneExt":22,"email":122},"Zlatko Mehmedbegović, MD","+381606678761","zlatkombegovic@gmail.com",{"name":120,"role":61,"phone":22,"phoneExt":22,"email":22},{"facility":60,"status":74,"city":125,"state":22,"zip":76,"country":95,"countryCode":97,"cosmosGeoPoint":126,"geoPoint":130,"contacts":131},"Kamenitz",{"type":80,"coordinates":127},[128,129],19.84263,45.22334,{"lat":129,"lon":128},[132,133,137],{"name":59,"role":64,"phone":65,"phoneExt":22,"email":66},{"name":134,"role":64,"phone":135,"phoneExt":22,"email":136},"Milovan Petrović, MD, PhD","+381641153076","petrovici@hotmail.com",{"name":59,"role":61,"phone":22,"phoneExt":22,"email":22},{"facility":139,"status":93,"city":140,"state":22,"zip":141,"country":95,"countryCode":97,"cosmosGeoPoint":142,"geoPoint":146,"contacts":147},"University Clinical Center of Kragujevac","Kragujevac","34000",{"type":80,"coordinates":143},[144,145],20.91667,44.01667,{"lat":145,"lon":144},[148,152],{"name":149,"role":64,"phone":150,"phoneExt":22,"email":151},"Miodrag Srećković, MD, PhD","+381693371777","sreckovic7@gmail.com",{"name":149,"role":61,"phone":22,"phoneExt":22,"email":22},{"type":61,"investigatorFullName":154,"investigatorTitle":155,"investigatorAffiliation":156,"oldNameTitle":22,"oldOrganization":22},"Mila Kovacevic","Assistant Professor, MD, PhD","University of Novi Sad","100573434","drug-eluting-balloon-or-drug-eluting-stent-in-acute-myocardial-infarction-a-randomized-controlled-trial-100573434",false,"NCT06746233","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.","BOOST-AMI","Inclusion Criteria:\n\n* Age \\>18 years with a life expectancy of \\>1 year;\n* 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)\n* 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.\n\nExclusion Criteria:\n\n* Killip class\\>II on admission\n* Known contraindication for aspirin, clopidogrel, ticagrelor, heparin or GP IIb\u002FIIIa inhibitor\n* Previous myocardial infarction\n* Previous PCI in the territory of the infarct-related artery (IRA)\n* Previous CABG\n* 3-vessel disease requiring revascularization\n* Left-main disease\n* Extremely angulated or severely calcified vessels\n* History of ischemic stroke within the past 6 months or hemorrhagic stroke\n* Planned CABG for a non-culprit vessel\n* Participation in another investigational trial that has not completed its primary endpoint or could interfere with the endpoints of this study","ALL","18 Years",{"count":168,"type":169},598,"ESTIMATED","INTERVENTIONAL",[172],"NA","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).\n\nRandomization 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.",[175],"ST Elevation Myocardial Infarction (STEMI)",[177,178,179],"STEMI","DES","DCB","2026-03-25",{"date":182,"type":183},"2026-03-30","ACTUAL",{"date":185,"type":183},"2024-12-25",{"date":187,"type":169},"2028-12",{"name":5,"class":6},5]