[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Fondazione Ricerca e Innovazione Cardiovascolare ETS\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":153},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,43,67,127],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":26,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":4},"100623004","the-piccoleto-ix-pheno-study-100623004",false,"NCT07390994","The PICCOLETO IX PHENO Study","Prognostic Impact of PHENOtyping de Novo Coronary Artery Disease Prior to Drug-Coated Balloon Angioplasty by Optical Coherence Tomography (PICCOLETO IX PHENO)","PIX-PHENO","Inclusion Criteria:\n\n* Chronic coronary syndrome or acute coronary syndrome diagnosis (per ESC guidelines).\n* De novo obstructive CAD: ≥50% left main stenosis, or any stenosis ≥70%, or FFR \\\u003C0.80 in any other major epicardial vessel, or MLA deemed ischemic at intravascular imaging.\n* OCT assessment of the target segment phenotype prior to lesion preparation and DCB angioplasty.\n* Successful DCB angioplasty according to DCB ARC criteria.\n* Patients who underwent DCB-only PCI, or hybrid DCB-DES PCI with at least 20 mm of the target segment treated with DCB.\n\nExclusion Criteria:\n\n* Previous revascularization of the target segment with stent.\n* Hybrid DCB-DES PCI with DCB-treated segment \\\u003C20 mm and\u002For lacking complete OCT assessment of the DCB-treated segment and\u002For bailout stenting.\n* Lack of at least 6 months of clinical follow up.\n* PCI of chronic total occlusion.","ALL","18 Years",{"count":20,"type":21},600,"ESTIMATED","OBSERVATIONAL","To investigate whether pre-procedural OCT-derived de novo coronary lesion phenotype (lipid-rich, fibrotic, calcific; and ACS mechanisms such as plaque rupture\u002Ferosion\u002Fcalcified nodule) is associated with clinical outcomes after DCB angioplasty.",[25],"Coronary Artery Disease",[27,28,29,30],"Drug-Coated Balloon","Optical Coherence Tomography","Percutaneous Coronary Intervention","Plaque phenotype","NOT_YET_RECRUITING","2026-01-29",{"date":34,"type":35},"2026-02-05","ACTUAL",{"date":37,"type":21},"2026-01-09",{"date":39,"type":21},"2027-04-20",{"name":41,"class":42},"Fondazione Ricerca e Innovazione Cardiovascolare ETS","OTHER",{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":51,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":53,"conditions":54,"keywords":56,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":61,"startDateStruct":62,"completionDateStruct":64,"leadSponsor":66,"locationsCount":4},"100623007","the-piccoleto-xi-a-prep-study-100623007","NCT07391033","The PICCOLETO XI A-PREP Study","Impact of Lesion PREParation With Modifying Balloons During Drug-coated Balloon (DCB) Angioplasty for In-stent Restenosis (ISR) - PICCOLETO XI A-PREP Study","PICCOLETO-XI","Inclusion Criteria:\n\n* Adult patients ≥18 years of age\n* Patients who underwent DCB angioplasty for in-stent restenosis\n\nExclusion Criteria:\n\n\\- Lack of clinical outcome assessment",{"count":52,"type":21},500,"To compare the angiographic and clinical outcomes of aggressive versus standard balloon preparation during drug-coated balloon (DCB) angioplasty for in-stent restenosis (ISR). The study will evaluate whether more aggressive lesion preparation with cutting\u002Fscoring\u002FOPN balloons improves outcomes compared to standard preparation with semi-compliant or non-compliant balloons.",[55,25],"In-Stent Coronary Artery Restenosis",[27,57,58,59,60,29],"In-Stent Restenosis","Lesion Preparation","Cutting Balloon","Scoring Balloon",{"date":34,"type":35},{"date":63,"type":21},"2026-06-01",{"date":65,"type":21},"2028-06-01",{"name":41,"class":42},{"id":68,"slug":69,"hasResults":11,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":73,"eligibilityCriteria":74,"healthyVolunteers":11,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":75,"targetDuration":4,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":106,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":118,"lastUpdatePostDateStruct":119,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},"100557242","single-vs-dual-antiplatelet-therapy-in-elderly-or-hbr-patients-undergoing-percutaneous-intervention-with-dcb-piccoleto-iv-epic-38-100557242","NCT06535568","Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO IV-EPIC 38)","International, Multicenter, Investigator-driven Randomized Clinical Trial to Assess the Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With Drug-coated Balloons (PICCOLETO IV-EPIC 38)","PIV-EPIC","Inclusion Criteria:\n\nMale and female patients who meet the following criteria:\n\n* Age ≥ 75 years or age ≥ 18 years at high bleeding risk;\n* Successful PCI with Essential Pro DCB just performed, in 1, 2 or 3 coronary vessels;\n* Stable or unstable coronary syndromes;\n* De novo coronary lesions in vessels with diameter ≥2.0 and ≤4.0 mm (visual estimation);\n* Informed consent to participate in the study given by the patient or impartial witness.\n\nExclusion Criteria:\n\n* Stent implantation during index or recent (\\\u003C6 months) procedure;\n* Known (and untreatable) hypersensitivity or contraindication to aspirin, heparin, clopidogrel, paclitaxel or contrast media, or any of their excipient which cannot be adequately pre-medicated;\n* Pregnancy at the time of hospitalization;\n* Patients participating in another clinical study in which an investigational drug or device was administered within 30 days of screening or within the 5 half-lives of the study drug, whichever is longer;\n* ST-elevation myocardial infarction;\n* Life expectancy \\\u003C12 months;\n* Left ventricular ejection fraction \\\u003C30%;\n* Visible 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 not mandatory);\n  * left main stem stenosis \\>50%;\n  * target lesion is in the left main stem;\n  * chronic total occlusion with anticipated necessity of retrograde approach;\n  * lesion is in a bypass graft.\n* History of asthma induced by the administration of salicylates or substances with a similar action, notably non-steroidal anti-inflammatory medicines (NSAIDs);\n* History of gastrointestinal perforation, ulceration, or bleeding (peptic ulcer bleeding-PUBs) related to previous use of NSAIDs or anticoagulant medications, or intracranial hemorrhage;\n* Acute gastrointestinal ulcers;\n* Hemorrhagic diathesis (including known bleeding disorders or ongoing active bleeding);\n* Severe renal impairment (eGFR \\\u003C 30 mL\u002Fmin);\n* Severe hepatic impairment (Child-Pugh C), with elevated liver enzymes (ALT\u002FAST \\> 2 x ULN or total bilirubin \\>1.5 x ULN);\n* Severe cardiac failure (NYHA grade III or IV);\n* Combination with methotrexate at doses of 15 mg\u002Fweek or more;\n* Patients with baseline neutrophil counts \\\u003C 1500 cells\u002Fmm³;\n* Breastfeeding women;\n* Full-blown thyrotoxicosis;\n* Patients with a very high risk of thrombosis.",{"count":76,"type":21},576,"INTERVENTIONAL",[79],"NA","This international, multicenter, open-label, randomized clinical trial evaluates the safety and efficacy of single antiplatelet therapy (SAPT) compared to dual antiplatelet therapy (DAPT) in elderly or high bleeding risk patients undergoing percutaneous coronary intervention (PCI) with the latest generation drug-coated balloon (DCB). The study includes patients with stable or unstable coronary syndromes and aims to assess rates of ischemic and bleeding adverse events.",[82,83,84,85,86,87,88,25,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105],"Coronary Disease","Heart Diseases","Cardiovascular Diseases","Myocardial Ischemia","Atherosclerosis","Arterial Occlusive Diseases","Vascular Diseases","Acute Coronary Syndrome","Coronary Stenosis","Molecular Mechanisms of Pharmacological Action","Enzyme Inhibitors","MTOR Inhibitors","Protein Kinase Inhibitors","Physiological Effects of Drugs","Immunosuppressive Agents","Antineoplastic Agents","High Bleeding Risk","Single Antiplatelet Therapy","Dual Antiplatelet Therapy","Cyclooxygenase Inhibitors","P2Y12 Inhibitor","Platelet Aggregation Inhibitors","Aspirin","Clopidogrel",[107,108,109,110,111,112,113,114,115,116],"DCB","Angioplasty","Paclitaxel","Antiplatelet treatment","Single antiplatelet therapy (SAPT)","Dual antiplatelet therapy (DAPT)","High bleeding risk (HBR)","MACE","Native CAD","stable or unstable coronary syndromes","RECRUITING","2026-01-21",{"date":120,"type":35},"2026-01-22",{"date":122,"type":35},"2026-01-10",{"date":124,"type":21},"2028-02-20",{"name":41,"class":42},1,{"id":128,"slug":129,"hasResults":11,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":133,"eligibilityCriteria":134,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":135,"targetDuration":4,"studyType":77,"phases":137,"briefSummary":138,"conditions":139,"keywords":140,"overallStatus":117,"whyStopped":4,"lastUpdateSubmitDate":144,"lastUpdatePostDateStruct":145,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":152},"100558480","dcb-vs-des-in-bifurcation-coronary-lesions-100558480","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)",{"count":136,"type":21},321,[79],"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.",[25,107],[141,142,143],"Coronary artery disease","Bifurcation coronary lesions","Drug-coated balloons","2025-11-27",{"date":146,"type":35},"2025-12-04",{"date":148,"type":35},"2025-08-01",{"date":150,"type":21},"2028-02-01",{"name":41,"class":42},17,""]