[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100624364":3},{"organization":4,"outcomesModule":7,"designInfo":85,"detailedDescription":84,"studyPopulation":84,"armGroups":93,"interventions":106,"overallOfficials":122,"centralContacts":127,"locations":84,"responsibleParty":137,"collaborators":139,"id":143,"slug":84,"hasResults":144,"nctId":145,"briefTitle":146,"officialTitle":147,"acronym":148,"eligibilityCriteria":149,"healthyVolunteers":144,"sex":150,"minAge":151,"maxAge":84,"enrollmentInfo":152,"targetDuration":84,"studyType":155,"phases":156,"briefSummary":158,"conditions":159,"keywords":163,"overallStatus":175,"whyStopped":84,"lastUpdateSubmitDate":176,"lastUpdatePostDateStruct":177,"startDateStruct":180,"completionDateStruct":182,"leadSponsor":184,"locationsCount":84},{"fullName":5,"class":6},"Rede Optimus Hospitalar SA","NETWORK",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":84},[9],{"measure":10,"description":11,"timeFrame":12},"Angiography-based late lumen loss","Angiography-based late lumen loss at the level of treated side-branch (primarily not stented branch)","12 months post procedure",[14,18,21,24,27,31,34,37,40,44,47,50,53,56,59,62,65,68,71,75,78,81],{"measure":15,"description":16,"timeFrame":17},"2. Late lumen loss","Late lumen loss at the level of proximal- and distal main branch (primarily stented branch)","at 12 months post procedure",{"measure":19,"description":20,"timeFrame":17},"Stent thrombosis rate","Stent thrombosis rate (acute, subacute, late) at 12 months.",{"measure":22,"description":23,"timeFrame":17},"Optical coherence tomography (OCT)-based minimal stent \u002F lumen area","Optical coherence tomography (OCT)-based minimal stent \u002F lumen area at the level of LM, LAD ostium and left circumflex (LCx) ostium at 12 months.",{"measure":25,"description":26,"timeFrame":17},"OCT-based area stenosis","OCT-based area stenosis at the level of LM, LAD ostium and LCx ostium",{"measure":28,"description":29,"timeFrame":30},"Acute lumen gain (2D)","Acute lumen gain based on 2D quantitative coronary angiography","at index procedure",{"measure":32,"description":33,"timeFrame":30},"Acute lumen gain (3D)","Acute lumen gain based on 3D quantitative coronary angiography",{"measure":35,"description":36,"timeFrame":30},"Acute functional result","Acute functional result in the LAD and in the LCx, defined by Murray law-based quantitative flow ratio (μQFR)",{"measure":38,"description":39,"timeFrame":17},"Functional result in the LAD and in the LCx","Functional result in the LAD and in the LCx, defined by μQFR",{"measure":41,"description":42,"timeFrame":43},"Delta μQFR in the LAD and in the LCx","Delta μQFR in the LAD and in the LCx between acute (index procedure) and 12 months follow-up","at index procedure and at12 months post procedure",{"measure":45,"description":46,"timeFrame":17},"Malposition rate","Malapposition rate by OCT",{"measure":48,"description":49,"timeFrame":17},"Underexpansion rate","Underexpansion rate by OCT",{"measure":51,"description":52,"timeFrame":17},"Diameter stenosis","Diameter stenosis based on quantitative coronary angiography at the level of LM, LAD ostium and LCx ostium",{"measure":54,"description":55,"timeFrame":17},"Area stenosis","Area stenosis based on 3D quantitative coronary angiography at the level of LM, LAD ostium and LCx ostium",{"measure":57,"description":58,"timeFrame":30},"Conversion rate","Conversion rate to double-stent technique",{"measure":60,"description":61,"timeFrame":30},"Procedure time","Duration of index procedure",{"measure":63,"description":64,"timeFrame":30},"Used contrast media","Used contrast media at index procedure",{"measure":66,"description":67,"timeFrame":30},"Radiation dose","Radiation dose at index procedure",{"measure":69,"description":69,"timeFrame":70},"Composite of death, myocardial infarction, target vessel revascularization, hospitalization for heart failure","at 6 months and 12 months pos procedure",{"measure":72,"description":73,"timeFrame":74},"Death","Death upon 12 months","from index procedure to 12 months post procedure",{"measure":76,"description":77,"timeFrame":74},"Myocardial Infarction","Myocardial Infarction upon 12 months.",{"measure":79,"description":80,"timeFrame":74},"Target vessel revascularization","Target vessel revascularization upon 12 months.",{"measure":82,"description":83,"timeFrame":74},"Hospitalization for heart failure","Hospitalization for heart failure upon 12 months.",null,{"allocation":86,"interventionModel":87,"interventionModelDescription":84,"primaryPurpose":88,"observationalModel":84,"timePerspective":84,"maskingInfo":89},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":90,"maskingDescription":84,"whoMasked":91},"SINGLE",[92],"PARTICIPANT",[94,100],{"label":95,"type":96,"description":97,"interventionNames":98},"Conventional Stenting","ACTIVE_COMPARATOR","Angiolite, iVascular",[99],"Device: Angiolite Sirolimus-Eluting Stenting",{"label":101,"type":102,"description":103,"interventionNames":104},"DBC-enhanced Stenting","EXPERIMENTAL","Essential Pro, iVascular",[105],"Device: Essential Pro Paclitaxel Drug-Eluting Balloon",[107,114],{"type":108,"name":109,"description":110,"armGroupLabels":111,"otherNames":112},"DEVICE","Angiolite Sirolimus-Eluting Stenting","Conventional Provisional Stenting",[95],[113],"Coronary Stent",{"type":108,"name":115,"description":116,"armGroupLabels":117,"otherNames":118},"Essential Pro Paclitaxel Drug-Eluting Balloon","Drug-Coated Balloon",[101],[119,120,121],"DBC","Drug Eluting Balloon","Drug Enhanced Balloon",[123],{"name":124,"affiliation":125,"role":126},"Gábor Tóth, MD, PhD","Medical University of Graz","PRINCIPAL_INVESTIGATOR",[128,133],{"name":129,"role":130,"phone":131,"phoneExt":84,"email":132},"Annelena Held, PhD, MSc","CONTACT","+49 157 86743867","annelena.held@redeoptimus.com",{"name":134,"role":130,"phone":135,"phoneExt":84,"email":136},"Melissa Munoz Beilis, MD","+49 176 720 75 997","melissa.munoz@redeoptimus.com",{"type":138,"investigatorFullName":84,"investigatorTitle":84,"investigatorAffiliation":84,"oldNameTitle":84,"oldOrganization":84},"SPONSOR",[140],{"name":141,"class":142},"iVascular S.L.U.","INDUSTRY","100624364",false,"NCT07408674","COMPETE-LM Trial: Drug-Coated Balloon-Enhanced Provisional Stenting in Complex Left Main Disease.","The COMPETE-LM Trial: A Physician-initiated Randomized Clinical Trial (RCT) Comparing Conventional Provisional Stenting With Drug-coated Balloon-enhanced Provisional Stenting for the Treatment of Complex Left Main (LM) Coronary Artery Disease.","COMPETE-LM","Inclusion Criteria:\n\n1. Distal left main stem bifurcation stenosis type Medina 1,1,1 or 0,1,1 with indication for revascularization.\n2. Left main diameter ≤6.00 mm.\n3. LAD and LCx diameter both \\>2.75 mm, evaluated by visual estimation.\n\nExclusion Criteria:\n\n1. Subjects with ages 18 or below at the time of the procedure.\n2. Female subjects who may be pregnant or breast-feeding at the time of the procedure.\n3. Previous PCI of the left main bifurcation.\n4. Chronic total occlusion of the LAD or LCx.\n5. Trifurcating left main requiring treatment of the 3 branches.\n6. LAD and LCx reference sizes are out of the sizing ranges of the used DES\u002FDCB families.\n7. In-stent restenosis as target lesion.\n8. Previous coronary artery bypass graft (CABG) with any patent graft on the left coronary system.\n9. ACS-STEMI (ST-Segment Elevation Myocardial Infarction) due to LM disease.\n10. Cardiogenic shock.\n11. Left ventricular ejection fraction below 35%.\n12. Decision to use mechanical circulatory support for protected PCI.\n13. Contraindication to a minimum of 3 months double antiplatelet and long-term single antiplatelet therapy (or adapted, in case of indication for anticoagulation).\n14. Associated significant valvular disease.\n15. Renal insufficiency with glomerular filtration rate (GFR) \\\u003C 20.\n16. Life expectancy less than one year.","ALL","18 Years",{"count":153,"type":154},186,"ESTIMATED","INTERVENTIONAL",[157],"NA","Prospective, physician-initiated, multicenter, randomized, single-blind, controlled trial.\n\nParticipants will be randomized (1:1) to a DCB-enhanced strategy (study group) or a conventional strategy (control group).\n\nThe study aims to compare the clinical outcomes of conventional provisional stenting (Angiolite in the main branch, with optional side branch stenting if compromised) versus DCB enhanced provisional stenting (Angiolite in the main branch plus Essential Pro in the side branch) in patients with complex left main bifurcation stenosis indicated to receive non-urgent percutaneous coronary intervention (PCI).\n\nTarget lesions, both main vessel and side branch, will be treated using iVascular devices, with patients randomized into two arms. In one arm, treatment will be performed exclusively with the Angiolite sirolimus-eluting stent (Angiolite, iVascular) in the main vessel, while in the other arm, the Angiolite will be used in the main vessel and the Essential Pro paclitaxel drug-eluting balloon (Essential Pro, iVascular) in the side branch. Non-target lesions may be treated with any commercially available devices according to their approved indications.",[160,161,162],"Complex Left Main Bifurcation Stenosis","Left Main Coronary Artery Stenosis","Coronary Bifurcation Stenosis",[164,165,166,161,167,168,169,170,171,120,172,173,174],"Essential Pro Paclitaxel","Angiolite","Left Main Artery","Left Main Coronary Artery","Left Main Bifurcation Stenosis","Coronary Disease","Coronary Artery Disease","Complex Left Main Disease","Drug Coated Balloon","Provisional Stenting","Sirolimus Eluting Stent","NOT_YET_RECRUITING","2026-02-06",{"date":178,"type":179},"2026-02-13","ACTUAL",{"date":181,"type":154},"2026-04",{"date":183,"type":154},"2029-05",{"name":5,"class":6}]