[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659718":3},{"organization":4,"outcomesModule":7,"designInfo":83,"detailedDescription":87,"studyPopulation":88,"armGroups":89,"interventions":84,"overallOfficials":93,"centralContacts":97,"locations":84,"responsibleParty":103,"collaborators":84,"id":105,"slug":106,"hasResults":107,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":107,"sex":113,"minAge":114,"maxAge":84,"enrollmentInfo":115,"targetDuration":84,"studyType":118,"phases":84,"briefSummary":119,"conditions":120,"keywords":126,"overallStatus":136,"whyStopped":84,"lastUpdateSubmitDate":137,"lastUpdatePostDateStruct":138,"startDateStruct":141,"completionDateStruct":143,"leadSponsor":145,"locationsCount":84},{"fullName":5,"class":6},"Fondazione Ricerca e Innovazione Cardiovascolare ETS","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":57},[9],{"measure":10,"description":11,"timeFrame":12},"Change in CCTA-Derived Total Coronary Plaque Volume (mm³)","Absolute change in total coronary plaque volume, expressed in cubic millimeters (mm³), within the DCB-treated coronary segment, calculated as follow-up total plaque volume minus baseline total plaque volume, as measured by an independent CCTA core laboratory.","Baseline to follow-up CCTA, performed 3 to 12 months after DCB angioplasty.",[14,17,21,24,27,30,33,36,39,42,45,48,51,54],{"measure":15,"description":16,"timeFrame":12},"Change in CCTA-Derived Calcified Plaque Volume (mm³)","Absolute change in calcified plaque volume, expressed in mm³, within the DCB-treated coronary segment, calculated as follow-up minus baseline calcified plaque volume.",{"measure":18,"description":19,"timeFrame":20},"Number of Lesions With Binary Restenosis at Follow-up (≥50% Diameter Stenosis)","Number of DCB-treated lesions with ≥50% diameter stenosis on follow-up CCTA.","Follow-up CCTA, performed 3 to 12 months after DCB angioplasty.",{"measure":22,"description":23,"timeFrame":12},"Change in CCTA-Derived Noncalcified Plaque Volume (mm³)","Absolute change in noncalcified plaque volume, expressed in mm³, within the DCB-treated coronary segment, calculated as follow-up minus baseline noncalcified plaque volume.",{"measure":25,"description":26,"timeFrame":12},"Change in CCTA-Derived Low-Attenuation Plaque Volume (mm³)","Absolute change in low-attenuation plaque volume, expressed in mm³, within the DCB-treated coronary segment, calculated as follow-up minus baseline low-attenuation plaque volume.",{"measure":28,"description":29,"timeFrame":12},"Change in Calcified Plaque Volume as a Percentage of Total Plaque Volume (%)","Change in the proportion of calcified plaque volume relative to total plaque volume within the DCB-treated coronary segment, expressed in percentage points, calculated as follow-up percentage minus baseline percentage.",{"measure":31,"description":32,"timeFrame":12},"Change in Noncalcified Plaque Volume as a Percentage of Total Plaque Volume (%)","Change in the proportion of noncalcified plaque volume relative to total plaque volume within the DCB-treated coronary segment, expressed in percentage points, calculated as follow-up percentage minus baseline percentage.",{"measure":34,"description":35,"timeFrame":12},"Change in Low-Attenuation Plaque Volume as a Percentage of Total Plaque Volume (%)","Change in the proportion of low-attenuation plaque volume relative to total plaque volume within the DCB-treated coronary segment, expressed in percentage points, calculated as follow-up percentage minus baseline percentage.",{"measure":37,"description":38,"timeFrame":12},"Change in CCTA-Derived Minimal Lumen Area (mm²)","Absolute change in minimal lumen area, expressed in mm², within the DCB-treated coronary segment, calculated as follow-up minus baseline minimal lumen area.",{"measure":40,"description":41,"timeFrame":12},"Change in CCTA-Derived Vessel Remodeling Index","Absolute change in the vessel remodeling index, defined as the ratio of lesion-site vessel area to reference-segment vessel area (a dimensionless ratio), within the DCB-treated coronary segment, calculated as follow-up minus baseline remodeling index.",{"measure":43,"description":44,"timeFrame":12},"Number of Lesions With a Change in Predominant Plaque Composition Category","Number of DCB-treated lesions in which the predominant plaque composition category (calcified, noncalcified, or mixed), assigned at baseline CCTA, differs from the category assigned at follow-up CCTA.",{"measure":46,"description":47,"timeFrame":20},"Number of Lesions With Positive Remodeling at Follow-up","Number of DCB-treated lesions classified as showing positive remodeling on follow-up CCTA, per the remodeling index threshold prespecified in the study protocol.",{"measure":49,"description":50,"timeFrame":20},"Number of Lesions With Low-Attenuation Plaque at Follow-up","Number of DCB-treated lesions with low-attenuation plaque identified on follow-up CCTA.",{"measure":52,"description":53,"timeFrame":20},"Number of Lesions With Spotty Calcification at Follow-up","Number of DCB-treated lesions with spotty calcification identified on follow-up CCTA.",{"measure":55,"description":56,"timeFrame":20},"Number of Lesions With Napkin-Ring Sign at Follow-up","Number of DCB-treated lesions with a napkin-ring sign identified on follow-up CCTA.",[58,62,65,68,71,73,75,77,79,81],{"measure":59,"description":60,"timeFrame":61},"Number of Participants With Target Lesion Failure","Clinical Outcome Measure - Number of participants experiencing target lesion failure, defined as the composite of cardiac death, target-vessel myocardial infarction, or clinically driven target lesion revascularization.","12 months.",{"measure":63,"description":64,"timeFrame":61},"Number of Participants With Any Myocardial Infarction (Target-Vessel or Non-Target-Vessel)","Clinical Outcome Measure - Number of participants experiencing myocardial infarction attributable to any coronary territory, target-vessel or non-target-vessel.",{"measure":66,"description":67,"timeFrame":61},"Number of Participants With BARC Type ≥3 Major Bleeding","Clinical Outcome Measure - Number of participants experiencing Bleeding Academic Research Consortium (BARC) type ≥3 bleeding, as defined in the study protocol.",{"measure":69,"description":70,"timeFrame":61},"Number of Participants With All-Cause Death","Clinical Outcome Measure.",{"measure":72,"description":70,"timeFrame":61},"Number of Participants With Cardiac Death",{"measure":74,"description":70,"timeFrame":61},"Number of Participants With Target-Vessel Myocardial Infarction",{"measure":76,"description":70,"timeFrame":61},"Number of Participants With Clinically Driven Target Lesion Revascularization",{"measure":78,"description":70,"timeFrame":61},"Number of Participants With Clinically Driven Target Vessel Revascularization",{"measure":80,"description":70,"timeFrame":61},"Number of Participants Hospitalized for Unstable Angina",{"measure":82,"description":70,"timeFrame":61},"Number of Participants With Stroke",{"allocation":84,"interventionModel":84,"interventionModelDescription":84,"primaryPurpose":84,"observationalModel":85,"timePerspective":86,"maskingInfo":84},null,"COHORT","RETROSPECTIVE","PICCOLETO XIII REVEAL-DCB Cohort A is an investigator-initiated, retrospective, international, multicenter observational cohort study evaluating CCTA-derived plaque and vessel changes after DCB-only percutaneous coronary intervention (PCI) for de novo coronary lesions.\n\nDrug-coated balloons have become an established option within the contemporary PCI armamentarium, in line with the \"leave nothing behind\" treatment strategy. By delivering an antiproliferative agent directly to the vessel wall without permanent implantation of a metallic scaffold, DCB aim to limit neointimal proliferation while promoting positive vessel remodeling, preserving native vessel physiology and the option for future revascularization.\n\nSerial angiographic and intracoronary imaging studies have described late lumen enlargement after DCB angioplasty, suggesting that the biological response to DCB treatment extends beyond the prevention of restenosis. However, the mechanisms underlying this phenomenon, and in particular the longitudinal changes in atherosclerotic plaque burden and composition after DCB treatment, remain incompletely characterized.\n\nCCTA provides a unique opportunity to investigate these processes noninvasively. Beyond assessment of luminal stenosis, contemporary CCTA allows quantitative characterization of vessel dimensions, total and component-specific plaque volumes and plaque burden, assessment of plaque phenotypes and high-risk plaque features, assessment of plaque remodeling and of changes in plaque composition during follow-up, and pre-procedural CCTA-assisted DCB angioplasty. Importantly, the absence of a permanent metallic scaffold after DCB-only PCI avoids stent-related blooming and beam-hardening artifacts, allowing direct serial assessment of both the coronary lumen and the vessel wall within the treated segment.\n\nConsecutive patients undergoing successful DCB-only PCI for a de novo coronary lesion will be identified from participating centers. Eligible patients will have either a diagnostic-quality CCTA performed before the index PCI and\u002For a diagnostic-quality follow-up CCTA performed within 12 months (minimum 3 months). If available, baseline and follow-up CCTA examinations will be anatomically matched at the lesion level to enable paired quantitative assessment of the same DCB-treated coronary segment over time. All imaging, procedural, and clinical data will derive from examinations and medical records obtained during routine clinical care.\n\nBaseline and follow-up CCTA examinations will be analyzed using a standardized protocol by an expert and independent core laboratory. Whenever feasible, paired examinations will be evaluated using the same dedicated quantitative plaque-analysis software, with comparable reconstruction parameters, and analyses will be performed by investigators blinded to procedural strategy and clinical outcomes.\n\nThis is an exploratory, hypothesis-generating retrospective study which does not require sample sizing assumptions. Its first aim is to understand the current state of the art in order to develop prospective studies with rigorous protocols.","Adult patients with coronary artery disease who underwent successful DCB-only PCI for at least 1 de novo coronary lesion at participating centers, with either a diagnostic-quality CCTA performed before the index PCI and\u002For a diagnostic-quality follow-up CCTA performed within 12 months (minimum 3 months).",[90],{"label":91,"type":84,"description":92,"interventionNames":84},"DCB-only PCI cohort","Adult patients who underwent successful drug-coated balloon-only PCI of at least 1 de novo coronary lesion, with a diagnostic-quality CCTA performed before the index PCI and\u002For a diagnostic-quality follow-up CCTA performed 3 to 12 months after DCB angioplasty, as part of routine clinical care.",[94],{"name":95,"affiliation":5,"role":96},"Bernardo Cortese, MD","STUDY_CHAIR",[98],{"name":99,"role":100,"phone":101,"phoneExt":84,"email":102},"Beatrice Barbano","CONTACT","+39 329 876 8658","segreteria@fondazioneric.org",{"type":104,"investigatorFullName":84,"investigatorTitle":84,"investigatorAffiliation":84,"oldNameTitle":84,"oldOrganization":84},"SPONSOR","100659718","the-piccoleto-xiii-reveal-dcb-cohort-a-study-100659718",false,"NCT07868523","The PICCOLETO XIII REVEAL-DCB Cohort A Study","REmodeling and pLaque Evolution After de Novo Coronary DCB Angioplasty: a Coronary Computed Tomography Angiography Study - The PICCOLETO XIII REVEAL-DCB Cohort A Study","REVEAL-DCB-A","Inclusion Criteria:\n\n* Age ≥18 years\n* Presence of ≥1 de novo coronary lesion treated with successful DCB-only PCI\n* No stent implantation within the target segment during the index procedure\n* Diagnostic-quality CCTA performed before the index PCI and\u002For diagnostic-quality follow-up CCTA performed 3 to 12 months after DCB angioplasty\n* Adequate visualization of the target vessel and treated segment on the available CCTA examination(s) to permit quantitative analysis\n* Availability of the index PCI angiogram and sufficient procedural data to identify the DCB-treated segment\n* Successful index PCI with an acceptable final angiographic result and stable clinical status at discharge\n\nExclusion Criteria:\n\n* In-stent restenosis as the target lesion\n* Bailout or planned stent implantation within the target segment during the index procedure\n* CCTA of insufficient diagnostic quality for quantitative analysis of the target segment because of severe calcification, motion artifact, misregistration, or other technical limitations\n* Follow-up CCTA performed outside the prespecified time window\n* Target-lesion revascularization before the scheduled follow-up CCTA, precluding paired imaging assessment of the untreated follow-up state\n* Inability to reliably identify and match the DCB-treated coronary segment between the index angiogram and baseline\u002Ffollow-up CCTA\n* Life expectancy less than 12 months from a non-cardiac cause","ALL","18 Years",{"count":116,"type":117},200,"ESTIMATED","OBSERVATIONAL","To characterize, using paired coronary computed tomography angiography (CCTA), longitudinal changes in coronary atherosclerotic plaque, lumen dimensions, and vessel remodeling between baseline and mid-term follow-up in de novo coronary lesions successfully treated with drug-coated balloon (DCB)-only angioplasty. No additional imaging examination, intervention, or clinical visit is mandated by the study protocol.",[121,122,123,124,125],"Coronary Artery Disease","Coronary Stenosis","Coronary Restenosis","Coronary Atherosclerosis","Vascular Remodeling",[127,128,129,130,131,132,133,134,135],"Drug-Coated Balloon","Coronary Computed Tomography Angiography","De Novo Coronary Lesion","Plaque Volume","Plaque Composition","Vessel Remodeling","Late Lumen Enlargement","Percutaneous Coronary Intervention","CAD-RADS","NOT_YET_RECRUITING","2026-10-06",{"date":139,"type":140},"2026-10-09","ACTUAL",{"date":142,"type":117},"2026-10",{"date":144,"type":117},"2027-04",{"name":5,"class":6}]