[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550558":3},{"organization":4,"outcomesModule":7,"designInfo":26,"detailedDescription":32,"studyPopulation":25,"armGroups":33,"interventions":44,"overallOfficials":25,"centralContacts":52,"locations":62,"responsibleParty":130,"collaborators":25,"id":132,"slug":25,"hasResults":133,"nctId":134,"briefTitle":135,"officialTitle":136,"acronym":25,"eligibilityCriteria":137,"healthyVolunteers":133,"sex":138,"minAge":139,"maxAge":25,"enrollmentInfo":140,"targetDuration":25,"studyType":143,"phases":144,"briefSummary":32,"conditions":146,"keywords":148,"overallStatus":65,"whyStopped":25,"lastUpdateSubmitDate":151,"lastUpdatePostDateStruct":152,"startDateStruct":155,"completionDateStruct":157,"leadSponsor":159,"locationsCount":160},{"fullName":5,"class":6},"Fundación EPIC","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":25},[9],{"measure":10,"description":11,"timeFrame":12},"Percentage of vessels with a positive response to Ach, defined as >4% change in the mean luminal diameter observed in the coronary segment distal (10-30 mm) to the treated segment, after the infusion of the maximum dose of ACh (10-6 mol\u002FL).","Percentage of vessels with a positive response to Ach, defined as \\>4% change in the mean luminal diameter observed in the coronary segment distal (10-30 mm) to the treated segment, after the infusion of the maximum dose of ACh (10-6 mol\u002FL).","8 months",[14,16,18,20,23],{"measure":15,"description":15,"timeFrame":12},"Comparison of percentage of angiographic restenosis by quantitative coronary",{"measure":17,"description":17,"timeFrame":12},"Comparison of the minimum luminal diameter of the treated segment by optical coronary tomography",{"measure":19,"description":19,"timeFrame":12},"Comparison of the minimum luminal area of the treated segment by optical coronary tomography",{"measure":21,"description":22,"timeFrame":12},"Percentage of of strut coverage by OCT(Optical Coherence Tomography) in the DES group","Percentage of of strut coverage by OCT in the DES group",{"measure":24,"description":24,"timeFrame":12},"Percentage of vessels with normal vascular architecture with correct definition of intima and media by optical coherence tomography in the drug-coated balloon group at 8 months",null,{"allocation":27,"interventionModel":28,"interventionModelDescription":25,"primaryPurpose":29,"observationalModel":25,"timePerspective":25,"maskingInfo":30},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":31,"maskingDescription":25,"whoMasked":25},"NONE","Randomized, controlled, open and multicenter study that analyzes the vasomotor function 8 months after use of the drug-eluting balloon (DCB) vs. drug-eluting stent (DES) in vessels ≥ 3.5 mm",[34,39],{"label":35,"type":36,"description":35,"interventionNames":37},"Drug Coated Balloon (DCB)","ACTIVE_COMPARATOR",[38],"Device: Drug Coated Balloon (DCB)",{"label":40,"type":41,"description":40,"interventionNames":42},"Drug Eluting Stent (DES)","EXPERIMENTAL",[43],"Device: Drug Eluting Stent (DES)",[45,49],{"type":46,"name":35,"description":47,"armGroupLabels":48,"otherNames":25},"DEVICE","Drug Coated Balloon (DCB) in patients with indication of Percutaneous Coronary Intervention (PCI)",[35],{"type":46,"name":40,"description":50,"armGroupLabels":51,"otherNames":25},"Drug Eluting Stent (DES) in patients with indication of Percutaneous Coronary Intervention (PCI)",[40],[53,58],{"name":54,"role":55,"phone":56,"phoneExt":25,"email":57},"IÑIGO LOZANO MARTINEZ-LUENGAS, MD, PhD","CONTACT","0034630901145","inigo.lozano@fundacionepic.org",{"name":59,"role":55,"phone":60,"phoneExt":25,"email":61},"FUNDACION EPIC","0034987876135","iepic@fundacionepic.org",[63,76,85,94,103,112,121],{"facility":64,"status":65,"city":66,"state":25,"zip":67,"country":68,"countryCode":69,"cosmosGeoPoint":70,"geoPoint":75,"contacts":25},"Hospital Universitari Vall d'Hebron","RECRUITING","Barcelona","08035","Spain","ES",{"type":71,"coordinates":72},"Point",[73,74],2.15899,41.38879,{"lat":74,"lon":73},{"facility":77,"status":65,"city":78,"state":25,"zip":79,"country":68,"countryCode":69,"cosmosGeoPoint":80,"geoPoint":84,"contacts":25},"Hospital Universitario de Cabueñes","Gijón","33394",{"type":71,"coordinates":81},[82,83],-5.66152,43.53573,{"lat":83,"lon":82},{"facility":86,"status":65,"city":87,"state":25,"zip":88,"country":68,"countryCode":69,"cosmosGeoPoint":89,"geoPoint":93,"contacts":25},"Hospital Universitario Juan Ramón Jiménez","Huelva","21005",{"type":71,"coordinates":90},[91,92],-6.94004,37.26638,{"lat":92,"lon":91},{"facility":95,"status":65,"city":96,"state":25,"zip":97,"country":68,"countryCode":69,"cosmosGeoPoint":98,"geoPoint":102,"contacts":25},"Hospital Universitario de Leon","León","24008",{"type":71,"coordinates":99},[100,101],-5.57032,42.60003,{"lat":101,"lon":100},{"facility":104,"status":65,"city":105,"state":25,"zip":106,"country":68,"countryCode":69,"cosmosGeoPoint":107,"geoPoint":111,"contacts":25},"Hospital Universitario Lucus Augusti","Lugo","270003",{"type":71,"coordinates":108},[109,110],-7.55602,43.00992,{"lat":110,"lon":109},{"facility":113,"status":65,"city":114,"state":25,"zip":115,"country":68,"countryCode":69,"cosmosGeoPoint":116,"geoPoint":120,"contacts":25},"Hospital Universitario Central de Asturias","Oviedo","33011",{"type":71,"coordinates":117},[118,119],-5.84476,43.36029,{"lat":119,"lon":118},{"facility":122,"status":65,"city":123,"state":25,"zip":124,"country":68,"countryCode":69,"cosmosGeoPoint":125,"geoPoint":129,"contacts":25},"Hospital Provincial de Pontevedra","Pontevedra","36071",{"type":71,"coordinates":126},[127,128],-8.64435,42.431,{"lat":128,"lon":127},{"type":131,"investigatorFullName":25,"investigatorTitle":25,"investigatorAffiliation":25,"oldNameTitle":25,"oldOrganization":25},"SPONSOR","100550558",false,"NCT06448637","DRUG RELEASING BALL vs. PHARMACOACTIVE STENT IN LARGE VESSELS: MORPHOLOGICAL ANALYSIS AND FUNCTION VASOMOTOR (DEBORA STUDY) IN LARGE VESSELS: MORPHOLOGICAL ANALYSIS AND FUNCTION VASOMOTOR (DEBORA STUDY)","DRUG RELEASING BALL vs. PHARMACOACTIVE STENT IN LARGE VESSELS: MORPHOLOGICAL ANALYSIS AND FUNCTION VASOMOTOR (DEBORA STUDY)","Inclusion Criteria:\n\nPatients who meet all of the following conditions are included.\n\n* Patients aged ≥ 18 years and;\n* Patients with chronic coronary syndrome, acute coronary syndrome without ST segment elevation or acute coronary syndrome with elevation ST segment in non-culprit lesions 48 hours after the event and;\n* Patients with de novo lesions in vessels ≥ 3.5 mm without calcification significant no visible thrombus and;\n* Patients who have been informed of the characteristics of the study and have provided their written informed consent.\n\nExclusion Criteria:\n\nPatients who meet at least one of the following conditions are excluded:\n\n* Patients with any contraindication for the administration of acetylcholine (ACh) or nitroglycerin (NTG).\n* Patients with a history of coronary vasospasm or spontaneous dissection of the coronary artery.\n* Patients with significant medical, surgical or psychiatric condition that would affect the safety of the subject or influence the outcome of the study according to the doctor's opinion.\n* Patients who received a combination of DES and DCB in the same vessel\n* Patients with glomerular filtration rate \\\u003C30 ml\u002Fmin\u002F 1.73 m2\n* Patients with body mass index \\>35 (may affect the evaluation qualitative diameter of the coronary artery).\n* Patients with symptomatic congestive heart failure.\n* Patients with significant autoimmune inflammatory conditions and patients taking immunomodulatory medications (including methotrexate, cyclosporine, steroids).\n* Patients with heart transplant.\n* Patients with anemia (Hb \\\u003C12 g\u002FdL in men and \\\u003C10 g\u002FdL in women).\n* Patients, women of childbearing age with a positive pregnancy test.\n* Pregnant female patients.\n* Patients included in other clinical trials with active follow-up.","ALL","18 Years",{"count":141,"type":142},94,"ESTIMATED","INTERVENTIONAL",[145],"NA",[147],"Coronary Artery Disease",[149,150],"Drug-coated balloon","Vasomotor function","2026-03-20",{"date":153,"type":154},"2026-03-23","ACTUAL",{"date":156,"type":154},"2024-10-23",{"date":158,"type":142},"2027-05-01",{"name":5,"class":6},7]