[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623004":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":35,"studyPopulation":36,"armGroups":32,"interventions":32,"overallOfficials":37,"centralContacts":42,"locations":32,"responsibleParty":50,"collaborators":32,"id":52,"slug":32,"hasResults":53,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":53,"sex":59,"minAge":60,"maxAge":32,"enrollmentInfo":61,"targetDuration":32,"studyType":64,"phases":32,"briefSummary":65,"conditions":66,"keywords":68,"overallStatus":73,"whyStopped":32,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":32},{"fullName":5,"class":6},"Fondazione Ricerca e Innovazione Cardiovascolare ETS","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"Clinically-driven Target Lesion Revascularization (TLR)","Any repeat revascularization (percutaneous or surgical) of the target lesion performed for recurrent symptoms or objective evidence of ischemia attributable to the target lesion.","12 months",[14,17,20,23,26,29],{"measure":15,"description":16,"timeFrame":12},"Device-Oriented Composite Endpoint (DOCE)","Composite of cardiac death, target-vessel myocardial infarction, and clinically-driven target lesion revascularization.",{"measure":18,"description":19,"timeFrame":12},"Target Vessel Revascularization (TVR)","Any repeat revascularization (percutaneous or surgical) of the target vessel.",{"measure":21,"description":22,"timeFrame":12},"All-cause Mortality","Death from any cause during the study follow-up period.",{"measure":24,"description":25,"timeFrame":12},"Cardiac Death","Death attributed to cardiovascular causes, including death from unknown cause.",{"measure":27,"description":28,"timeFrame":12},"Target-Vessel Myocardial Infarction (TV-MI)","Myocardial infarction attributable to the target vessel based on clinical, electrocardiographic, and biomarker criteria according to the Fourth Universal Definition of Myocardial Infarction.",{"measure":30,"description":31,"timeFrame":12},"Any Myocardial Infarction","Any myocardial infarction (target-vessel or non-target-vessel) according to the Fourth Universal Definition of Myocardial Infarction.",null,{"allocation":32,"interventionModel":32,"interventionModelDescription":32,"primaryPurpose":32,"observationalModel":34,"timePerspective":6,"maskingInfo":32},"COHORT","PICCOLETO IX PHENO is an investigator-initiated, multicenter, international, ambispective (retrospective and prospective) cohort study enrolling patients who underwent DCB angioplasty for de novo coronary artery disease with preprocedural OCT assessment of the target segment. OCT images (baseline mandatory; post-preparation and post-PCI when available) and angiography will be analyzed by independent core laboratories; clinical events will be adjudicated by an independent committee. The primary endpoint is clinically-driven target lesion revascularization at 12 months; secondary endpoints include device-oriented composite endpoint (cardiac death, TLR, target-vessel MI), target vessel revascularization, MI endpoints, and mortality.","Adult patients with chronic coronary syndrome or acute coronary syndrome who underwent drug-coated balloon angioplasty for de novo obstructive coronary artery disease with preprocedural optical coherence tomography assessment of the target segment.",[38],{"name":39,"affiliation":40,"role":41},"Filippo Luca Gurgoglione","A.O.U. di Parma","PRINCIPAL_INVESTIGATOR",[43,48],{"name":44,"role":45,"phone":46,"phoneExt":32,"email":47},"Filippo Gurguglione","CONTACT","+393312048150","mailto:filippolucagurgoglione@gmail.com",{"name":49,"role":45,"phone":32,"phoneExt":32,"email":32},"Beatrice Barbano",{"type":51,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR","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":62,"type":63},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.",[67],"Coronary Artery Disease",[69,70,71,72],"Drug-Coated Balloon","Optical Coherence Tomography","Percutaneous Coronary Intervention","Plaque phenotype","NOT_YET_RECRUITING","2026-01-29",{"date":76,"type":77},"2026-02-05","ACTUAL",{"date":79,"type":63},"2026-01-09",{"date":81,"type":63},"2027-04-20",{"name":5,"class":6}]