[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623007":3},{"organization":4,"outcomesModule":7,"designInfo":44,"detailedDescription":47,"studyPopulation":48,"armGroups":49,"interventions":43,"overallOfficials":56,"centralContacts":67,"locations":43,"responsibleParty":75,"collaborators":43,"id":77,"slug":43,"hasResults":78,"nctId":79,"briefTitle":80,"officialTitle":81,"acronym":82,"eligibilityCriteria":83,"healthyVolunteers":78,"sex":84,"minAge":85,"maxAge":43,"enrollmentInfo":86,"targetDuration":43,"studyType":89,"phases":43,"briefSummary":90,"conditions":91,"keywords":94,"overallStatus":101,"whyStopped":43,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":43},{"fullName":5,"class":6},"Fondazione Ricerca e Innovazione Cardiovascolare ETS","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":43},[9],{"measure":10,"description":11,"timeFrame":12},"Major Adverse Cardiovascular Events (MACE)","Composite of cardiac death, non-fatal myocardial infarction (MI), or target lesion revascularization (TLR).","12 months",[14,18,21,24,27,30,34,37,40],{"measure":15,"description":16,"timeFrame":17},"Cardiac Death","Death attributed to cardiovascular causes, including death from unknown cause.","12 months and longest available follow-up",{"measure":19,"description":20,"timeFrame":17},"Non-fatal Myocardial Infarction","Non-fatal myocardial infarction according to the Fourth Universal Definition of Myocardial Infarction.",{"measure":22,"description":23,"timeFrame":17},"Target Lesion Revascularization (TLR)","Any repeat revascularization (percutaneous or surgical) of the target lesion.",{"measure":25,"description":26,"timeFrame":17},"Target Vessel Myocardial Infarction (TV-MI)","Myocardial infarction attributable to the target vessel based on clinical, electrocardiographic, and biomarker criteria.",{"measure":28,"description":29,"timeFrame":17},"BARC Major Bleeding","Bleeding Academic Research Consortium (BARC) major bleeding events (type 3-5).",{"measure":31,"description":32,"timeFrame":33},"Procedural Success","Successful DCB angioplasty with residual stenosis less than 30% and TIMI flow grade 3 without major procedural complications.","At procedure",{"measure":35,"description":36,"timeFrame":33},"Post-procedural Diameter Stenosis","Percentage of diameter stenosis after DCB angioplasty assessed by quantitative coronary angiography.",{"measure":38,"description":39,"timeFrame":33},"Angiographic Dissection","Presence and type of coronary dissection after lesion preparation and DCB treatment.",{"measure":41,"description":42,"timeFrame":33},"TIMI Flow Grade","Thrombolysis In Myocardial Infarction (TIMI) flow grade assessment post-procedure.",null,{"allocation":43,"interventionModel":43,"interventionModelDescription":43,"primaryPurpose":43,"observationalModel":45,"timePerspective":46,"maskingInfo":43},"COHORT","RETROSPECTIVE","PICCOLETO XI A-PREP is an investigator-initiated, multicenter, international, observational study evaluating the impact of lesion preparation strategies on outcomes following drug-coated balloon (DCB) angioplasty for in-stent restenosis (ISR).\n\nIn-stent restenosis remains a clinically relevant challenge despite advances in drug-eluting stent technology and contemporary percutaneous coronary intervention techniques. DCB represents a stentless therapeutic strategy for ISR treatment, with the advantage of avoiding implantation of additional metallic layers.\n\nA key determinant of clinical outcomes in ISR, particularly with DCB angioplasty, is the adequacy of lesion preparation before definitive therapy. Effective preparation facilitates optimal drug delivery, improves luminal gain, and may reduce the risk of recurrent restenosis.\n\nA large spectrum of balloon-based modalities is available for ISR lesion preparation, ranging from semi-compliant and non-compliant balloons to more aggressive tools such as scoring and cutting balloons. Although more aggressive devices may enhance plaque modification and neointimal tissue disruption, their incremental clinical benefit over standard approaches remains uncertain.\n\nPatients will be categorized into two groups based on lesion preparation strategy:\n\n* Aggressive preparation: Cutting\u002FWolverine balloons, scoring balloons (any brand), and\u002For OPN balloons\n* Standard preparation: Semi-compliant balloons and\u002For non-compliant balloons\n\nClinical outcomes will be assessed at 1-year and longest available follow-up.","Adult patients who underwent drug-coated balloon (DCB) angioplasty for in-stent restenosis (ISR) at participating centers.",[50,53],{"label":51,"type":43,"description":52,"interventionNames":43},"Aggressive Lesion Preparation","Patients who underwent lesion preparation using cutting\u002FWolverine balloons, scoring balloons (any brand), and\u002For OPN balloons prior to DCB angioplasty for ISR.",{"label":54,"type":43,"description":55,"interventionNames":43},"Standard Lesion Preparation","Patients who underwent lesion preparation using semi-compliant balloons and\u002For non-compliant balloons prior to DCB angioplasty for ISR.",[57,61,64],{"name":58,"affiliation":59,"role":60},"Bharat Khialani, MD","Tan Tock Seng Hospital, National Healthcare Group, Singapore","PRINCIPAL_INVESTIGATOR",{"name":62,"affiliation":63,"role":60},"Filippo Luca Gurgoglione, MD, PhD","Department of Cardiology, Parma University Hospital, Parma, Italy",{"name":65,"affiliation":5,"role":66},"Bernardo Cortese, MD","STUDY_CHAIR",[68,72],{"name":62,"role":69,"phone":70,"phoneExt":43,"email":71},"CONTACT","+393312048150","filippolucagurgoglione@gmail.com",{"name":73,"role":69,"phone":43,"phoneExt":43,"email":74},"Beatrice Barbano","segreteria@fondazioneric.org",{"type":76,"investigatorFullName":43,"investigatorTitle":43,"investigatorAffiliation":43,"oldNameTitle":43,"oldOrganization":43},"SPONSOR","100623007",false,"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","ALL","18 Years",{"count":87,"type":88},500,"ESTIMATED","OBSERVATIONAL","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.",[92,93],"In-Stent Coronary Artery Restenosis","Coronary Artery Disease",[95,96,97,98,99,100],"Drug-Coated Balloon","In-Stent Restenosis","Lesion Preparation","Cutting Balloon","Scoring Balloon","Percutaneous Coronary Intervention","NOT_YET_RECRUITING","2026-01-29",{"date":104,"type":105},"2026-02-05","ACTUAL",{"date":107,"type":88},"2026-06-01",{"date":109,"type":88},"2028-06-01",{"name":5,"class":6}]