[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100573434":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":31,"centralContacts":36,"locations":45,"responsibleParty":127,"collaborators":26,"id":131,"slug":132,"hasResults":133,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":137,"eligibilityCriteria":138,"healthyVolunteers":133,"sex":139,"minAge":140,"maxAge":26,"enrollmentInfo":141,"targetDuration":26,"studyType":144,"phases":145,"briefSummary":147,"conditions":148,"keywords":150,"overallStatus":48,"whyStopped":26,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},{"fullName":5,"class":6},"Institute of Cardiovascular Diseases, Vojvodina","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Drug coated balloon (DCB)","EXPERIMENTAL","Drug (paclitaxel) coated balloon (DCB) with concentration of 3-3.5 μg Paclitaxel per 1 mm2",[13],"Device: Drug (paclitaxel) coated balloon (DCB)",{"label":15,"type":16,"description":17,"interventionNames":18},"Second generation of drug eluting stents (DES)","ACTIVE_COMPARATOR","Drug eluting stent (DES)",[19],"Device: Second-generation Drug Eluting Stent (DES)",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"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.",[9],null,{"type":22,"name":28,"description":29,"armGroupLabels":30,"otherNames":26},"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",[15],[32],{"name":33,"affiliation":34,"role":35},"Mila Kovačević, MD, PhD","Institute of Cardiovascular Diseases of Vojvodina","PRINCIPAL_INVESTIGATOR",[37,41],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},"CONTACT","+381601594444","milakov979@gmail.com",{"name":42,"role":38,"phone":43,"phoneExt":26,"email":44},"Branislav Crnomarković, MD","+381642636495","branislavc.89@gmail.com",[46,65,83,98,112],{"facility":47,"status":48,"city":49,"state":26,"zip":50,"country":51,"countryCode":52,"cosmosGeoPoint":53,"geoPoint":58,"contacts":59},"University Clinical Centre of the Republic of Srpska","RECRUITING","Banja Luka","21204","Bosnia and Herzegovina","BA",{"type":54,"coordinates":55},"Point",[56,57],17.20629,44.77879,{"lat":57,"lon":56},[60,64],{"name":61,"role":38,"phone":62,"phoneExt":26,"email":63},"Bojan Stanetić, MD, PhD","+38765614340","bojan.stanetic@gmail.com",{"name":61,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":66,"status":67,"city":68,"state":69,"zip":70,"country":69,"countryCode":71,"cosmosGeoPoint":72,"geoPoint":76,"contacts":77},"University Clinical Centre of Nis","NOT_YET_RECRUITING","Niš","Serbia","18105","RS",{"type":54,"coordinates":73},[74,75],21.90333,43.32472,{"lat":75,"lon":74},[78,82],{"name":79,"role":38,"phone":80,"phoneExt":26,"email":81},"Bojan Maričić, MD, PhD","+381692918755","bokimaricic@gmail.com",{"name":79,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":84,"status":48,"city":85,"state":26,"zip":86,"country":69,"countryCode":71,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"University Clinical Center of Serbia","Belgrade","11000",{"type":54,"coordinates":88},[89,90],20.46513,44.80401,{"lat":90,"lon":89},[93,97],{"name":94,"role":38,"phone":95,"phoneExt":26,"email":96},"Zlatko Mehmedbegović, MD","+381606678761","zlatkombegovic@gmail.com",{"name":94,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":34,"status":48,"city":99,"state":26,"zip":50,"country":69,"countryCode":71,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"Kamenitz",{"type":54,"coordinates":101},[102,103],19.84263,45.22334,{"lat":103,"lon":102},[106,107,111],{"name":33,"role":38,"phone":39,"phoneExt":26,"email":40},{"name":108,"role":38,"phone":109,"phoneExt":26,"email":110},"Milovan Petrović, MD, PhD","+381641153076","petrovici@hotmail.com",{"name":33,"role":35,"phone":26,"phoneExt":26,"email":26},{"facility":113,"status":67,"city":114,"state":26,"zip":115,"country":69,"countryCode":71,"cosmosGeoPoint":116,"geoPoint":120,"contacts":121},"University Clinical Center of Kragujevac","Kragujevac","34000",{"type":54,"coordinates":117},[118,119],20.91667,44.01667,{"lat":119,"lon":118},[122,126],{"name":123,"role":38,"phone":124,"phoneExt":26,"email":125},"Miodrag Srećković, MD, PhD","+381693371777","sreckovic7@gmail.com",{"name":123,"role":35,"phone":26,"phoneExt":26,"email":26},{"type":35,"investigatorFullName":128,"investigatorTitle":129,"investigatorAffiliation":130,"oldNameTitle":26,"oldOrganization":26},"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":142,"type":143},598,"ESTIMATED","INTERVENTIONAL",[146],"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.",[149],"ST Elevation Myocardial Infarction (STEMI)",[151,152,153],"STEMI","DES","DCB","2026-03-25",{"date":156,"type":157},"2026-03-30","ACTUAL",{"date":159,"type":157},"2024-12-25",{"date":161,"type":143},"2028-12",{"name":5,"class":6},5]