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Cortese","CONTACT","504827636","bcortese@gmail.com",{"name":42,"role":38,"phone":39,"phoneExt":11,"email":43},"Wojciech Wańha","wojciech.wanha@gmail.com",[45,61,82,101,117,128,141,153,170,182,193,206,217,230,244,260,273],{"facility":46,"status":47,"city":48,"state":11,"zip":11,"country":49,"countryCode":50,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Fondazione Ricerca e Innovazione Cardiovascolare","NOT_YET_RECRUITING","Milan","Italy","IT",{"type":52,"coordinates":53},"Point",[54,55],12.59836,42.78235,{"lat":55,"lon":54},[58,59],{"name":37,"role":38,"phone":11,"phoneExt":11,"email":11},{"name":37,"role":60,"phone":11,"phoneExt":11,"email":11},"PRINCIPAL_INVESTIGATOR",{"facility":62,"status":47,"city":63,"state":11,"zip":11,"country":64,"countryCode":65,"cosmosGeoPoint":66,"geoPoint":70,"contacts":71},"First Department of Cardiology, Medical University of Gdansk, Gdansk, Poland","Gdansk","Poland","PL",{"type":52,"coordinates":67},[68,69],18.64912,54.35227,{"lat":69,"lon":68},[72,75,78,80],{"name":73,"role":38,"phone":11,"phoneExt":11,"email":74},"Maksymilian Mielczarek, Prof.","max.mielczarek@gmail.com",{"name":76,"role":77,"phone":11,"phoneExt":11,"email":11},"Miłosz Jaguszewski, Prof.","SUB_INVESTIGATOR",{"name":79,"role":60,"phone":11,"phoneExt":11,"email":11},"Maksymilian Mielczarek, MD, PhD",{"name":81,"role":77,"phone":11,"phoneExt":11,"email":11},"Dariusz Cieświerz, MD, PhD",{"facility":83,"status":47,"city":84,"state":11,"zip":85,"country":64,"countryCode":65,"cosmosGeoPoint":86,"geoPoint":90,"contacts":91},"Department of Cardiology and Structural Heart Diseases, Medical University of Silesia, Katowice, Poland","Katowice","40-635",{"type":52,"coordinates":87},[88,89],19.02173,50.2597,{"lat":89,"lon":88},[92,95,97,99],{"name":93,"role":38,"phone":94,"phoneExt":11,"email":43},"Wojciech Wańha, MD, 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Prof.",{"facility":118,"status":47,"city":103,"state":11,"zip":11,"country":64,"countryCode":65,"cosmosGeoPoint":119,"geoPoint":121,"contacts":122},"Second Department of Cardiology, Jagiellonian University Medical College, Krakow, Poland",{"type":52,"coordinates":120},[106,107],{"lat":107,"lon":106},[123,127],{"name":124,"role":38,"phone":125,"phoneExt":11,"email":126},"Stanisław Bartuś, Prof.","12 400 22 50","mbbartus@gmail.com",{"name":124,"role":60,"phone":11,"phoneExt":11,"email":11},{"facility":129,"status":47,"city":130,"state":11,"zip":11,"country":64,"countryCode":65,"cosmosGeoPoint":131,"geoPoint":135,"contacts":136},"Department of Cardiology, Copper Health Centre (MCZ)","Lubin",{"type":52,"coordinates":132},[133,134],16.20149,51.40089,{"lat":134,"lon":133},[137,140],{"name":138,"role":38,"phone":11,"phoneExt":11,"email":139},"Adrian Włodarczak, MD, PhD","wlodarczak.adrian@gmail.com",{"name":138,"role":60,"phone":11,"phoneExt":11,"email":11},{"facility":142,"status":47,"city":143,"state":11,"zip":11,"country":64,"countryCode":65,"cosmosGeoPoint":144,"geoPoint":148,"contacts":149},"Clinical Department of Interventional Cardiology, Medical University of Lublin","Lublin",{"type":52,"coordinates":145},[146,147],22.57009,51.25058,{"lat":147,"lon":146},[150],{"name":151,"role":38,"phone":11,"phoneExt":11,"email":152},"Piotr Waciński","piotr.j.wacinski@gmail.com",{"facility":154,"status":47,"city":155,"state":11,"zip":11,"country":64,"countryCode":65,"cosmosGeoPoint":156,"geoPoint":160,"contacts":161},"Department of Cardiology, Poznan University of Medical Sciences","Poznan",{"type":52,"coordinates":157},[158,159],16.92993,52.40692,{"lat":159,"lon":158},[162,165,166,168],{"name":163,"role":38,"phone":11,"phoneExt":11,"email":164},"Sylwia Iwańczyk, MD, 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Medicine","Warsaw",{"type":52,"coordinates":186},[187,188],21.01178,52.22977,{"lat":188,"lon":187},[191],{"name":192,"role":38,"phone":11,"phoneExt":11,"email":11},"Piotr Kwiatkowski, MD",{"facility":194,"status":47,"city":184,"state":11,"zip":11,"country":64,"countryCode":65,"cosmosGeoPoint":195,"geoPoint":197,"contacts":198},"Department of Invasive Cardiology, Centre of Postgraduate Medical Education, Central Clinical Hospital of the Ministry of Interior and Administration",{"type":52,"coordinates":196},[187,188],{"lat":188,"lon":187},[199,203,204],{"name":200,"role":38,"phone":201,"phoneExt":11,"email":202},"Robert Gil, Prof.","(22) 508 11 00","scorpirg@gmail.com",{"name":200,"role":60,"phone":11,"phoneExt":11,"email":11},{"name":205,"role":60,"phone":11,"phoneExt":11,"email":11},"Tomasz Pawłowski, Prof.",{"facility":207,"status":47,"city":208,"state":11,"zip":11,"country":64,"countryCode":65,"cosmosGeoPoint":209,"geoPoint":213,"contacts":214},"Department of 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Katowice","Zabrze",{"type":52,"coordinates":234},[235,236],18.78576,50.32492,{"lat":236,"lon":235},[239,243],{"name":240,"role":38,"phone":241,"phoneExt":11,"email":242},"Mariusz Gąsior, Prof.","32 373 36 00","m.gasior@op.pl",{"name":240,"role":60,"phone":11,"phoneExt":11,"email":11},{"facility":245,"status":246,"city":247,"state":11,"zip":11,"country":248,"countryCode":249,"cosmosGeoPoint":250,"geoPoint":254,"contacts":255},"Heart Institute, Cluj-Napoca","RECRUITING","Cluj-Napoca","Romania","RO",{"type":52,"coordinates":251},[252,253],23.6,46.76667,{"lat":253,"lon":252},[256],{"name":257,"role":38,"phone":258,"phoneExt":11,"email":259},"Alexandru Achim, MD","0040753803716","dr.alex.achim@gmail.com",{"facility":261,"status":246,"city":262,"state":11,"zip":11,"country":248,"countryCode":249,"cosmosGeoPoint":263,"geoPoint":267,"contacts":268},"Sibiu County Emergency Clinical Hospital","Sibiu",{"type":52,"coordinates":264},[265,266],24.15,45.8,{"lat":266,"lon":265},[269],{"name":270,"role":38,"phone":271,"phoneExt":11,"email":272},"Leontin Lazar, MD","0040747805999","lazar.leontin@yahoo.com",{"facility":274,"status":47,"city":275,"state":11,"zip":11,"country":275,"countryCode":276,"cosmosGeoPoint":277,"geoPoint":281,"contacts":282},"Tan Tock Seng Hospital","Singapore","SG",{"type":52,"coordinates":278},[279,280],103.85007,1.28967,{"lat":280,"lon":279},[283],{"name":284,"role":38,"phone":11,"phoneExt":11,"email":285},"Bharat Khialani","drbkhialani@gmail.com",{"type":287,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100558480","dcb-vs-des-in-bifurcation-coronary-lesions-100558480",false,"NCT06551662","DCB vs. DES in Bifurcation Coronary Lesions","Drug-coated Balloons vs. Drug Eluting Stents in Bifurcation Coronary Lesions: PICCOLETO V Study","PICCOLETO V","Inclusion Criteria:\n\n* Subject must be age ≥18 years.\n* Subject has silent ischemia, or stable\u002Funstable angina, or acute MI older than 1-week from the onset of chest pain to admission.\n* Subject understands the trial design and treatment procedures and provides written informal consent before entering the trial\n* Subject is willing to comply with all protocol-required follow-up evaluations.\n* Target lesion must be native non-LM bifurcation lesion\n* Target lesion must be a bifurcation lesion on coronary angiography (defined as Medina 0,1,1, Medina 1,0,1, Medina 1,1,1 or Medina 0,0,1 coronary bifurcation lesions) and is eligible for percutaneous coronary intervention (PCI).\n* Target lesion reference vessel diameter (both main vessel and side branch)\n\n  * 2.0 mm by visual estimation.\n* Target lesion must have visually estimated stenosis ≥50%.\n* Target lesion length of side branch must be \\\u003C25 mm by visual estimation.\n\nExclusion Criteria:\n\n* Patient with STEMI (within 3 days from the onset of chest pain to coronarography).\n* Patient has known allergy to the study balloon\u002Fstent system.\n* Patient has any other serious medical illness that may reduce life expectancy to less than 12 months.\n* Patient is pregnant or nursing.\n* Patient is participating in another clinical trial that has not reached its primary endpoint within 24 months after the index procedure.\n* Patient has a planned procedure that may cause non-compliance with the protocol or confound data interpretation.\n* In-stent restenosis lesion.\n* Chronic total occlusion (CTO) lesion in either main vessel or side branch.\n* Left ventricular ejection fraction \\\u003C30%;\n* Visible and untreatable thrombus at lesion site;\n* Target lesion\u002Fvessel with any of the following characteristics:\n\n  * Severe and\u002For \\>270° calcification of the target vessel, also proximal to the lesion (intravascular imaging);\n  * Bifurcation lesion where stent strategy is anticipated;\n  * Left main stem stenosis \\>50%;\n  * Target lesion is in the left main stem;\n  * Lesions length \\>50 mm (main vessel)\n  * Lesions length \\>25 mm (side branch)","ALL","18 Years",{"count":299,"type":300},321,"ESTIMATED","INTERVENTIONAL",[303],"NA","This is an investigator-driven prospective, multicentric, international, randomized clinical study, in an open-label randomized fashion, where patients with bifurcation coronary artery disease (Medina: 111,101,011,001) in vessels with diameter \\>2.0 (visual estimation) and with a clinical indication to PCI, will be enrolled. After successful predilatation (with any tool deemed useful), patients will be randomized 1:1:1 to SCB, PCB or standard treatment with DES for bifurcation native vessel disease. All patients with a clinical indication for PCI, both stable coronary artery disease and acute coronary syndrome, will be enrolled.\n\nBefore participating all the candidates will be clearly informed about the study, including the possible risks and benefits, and will be asked to provide a written informed consent. Subjects will be instructed that may not meet the general criteria for inclusion or the angiographic criteria, or that may have at least one exclusion criteria, and then be excluded from the study (screening failure), even after informed consent is obtained.\n\nConsecutive patients who meet at least one of the inclusion criteria and none of the exclusion criteria, will participate to the study. After randomization, the procedure will consist in standard coronary angioplasty following international guidelines\u002Fconsensus documents and as per local practice. If the patient has been randomized to SCB or PCB, it is mandatory to adequately prepare the lesion.",[306,307],"Coronary Artery Disease","DCB",[309,310,311],"Coronary artery disease","Bifurcation coronary lesions","Drug-coated balloons","2025-11-27",{"date":314,"type":315},"2025-12-04","ACTUAL",{"date":317,"type":315},"2025-08-01",{"date":319,"type":300},"2028-02-01",{"name":5,"class":6},17]