[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100550558":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":23,"centralContacts":27,"locations":37,"responsibleParty":105,"collaborators":23,"id":107,"slug":108,"hasResults":109,"nctId":110,"briefTitle":111,"officialTitle":112,"acronym":23,"eligibilityCriteria":113,"healthyVolunteers":109,"sex":114,"minAge":115,"maxAge":23,"enrollmentInfo":116,"targetDuration":23,"studyType":119,"phases":120,"briefSummary":122,"conditions":123,"keywords":125,"overallStatus":40,"whyStopped":23,"lastUpdateSubmitDate":128,"lastUpdatePostDateStruct":129,"startDateStruct":132,"completionDateStruct":134,"leadSponsor":136,"locationsCount":137},{"fullName":5,"class":6},"Fundación EPIC","OTHER",[8,13],{"label":9,"type":10,"description":9,"interventionNames":11},"Drug Coated Balloon (DCB)","ACTIVE_COMPARATOR",[12],"Device: Drug Coated Balloon (DCB)",{"label":14,"type":15,"description":14,"interventionNames":16},"Drug Eluting Stent (DES)","EXPERIMENTAL",[17],"Device: Drug Eluting Stent (DES)",[19,24],{"type":20,"name":9,"description":21,"armGroupLabels":22,"otherNames":23},"DEVICE","Drug Coated Balloon (DCB) in patients with indication of Percutaneous Coronary Intervention (PCI)",[9],null,{"type":20,"name":14,"description":25,"armGroupLabels":26,"otherNames":23},"Drug Eluting Stent (DES) in patients with indication of Percutaneous Coronary Intervention (PCI)",[14],[28,33],{"name":29,"role":30,"phone":31,"phoneExt":23,"email":32},"IÑIGO LOZANO MARTINEZ-LUENGAS, MD, PhD","CONTACT","0034630901145","inigo.lozano@fundacionepic.org",{"name":34,"role":30,"phone":35,"phoneExt":23,"email":36},"FUNDACION EPIC","0034987876135","iepic@fundacionepic.org",[38,51,60,69,78,87,96],{"facility":39,"status":40,"city":41,"state":23,"zip":42,"country":43,"countryCode":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":23},"Hospital Universitari Vall d'Hebron","RECRUITING","Barcelona","08035","Spain","ES",{"type":46,"coordinates":47},"Point",[48,49],2.15899,41.38879,{"lat":49,"lon":48},{"facility":52,"status":40,"city":53,"state":23,"zip":54,"country":43,"countryCode":44,"cosmosGeoPoint":55,"geoPoint":59,"contacts":23},"Hospital Universitario de Cabueñes","Gijón","33394",{"type":46,"coordinates":56},[57,58],-5.66152,43.53573,{"lat":58,"lon":57},{"facility":61,"status":40,"city":62,"state":23,"zip":63,"country":43,"countryCode":44,"cosmosGeoPoint":64,"geoPoint":68,"contacts":23},"Hospital Universitario Juan Ramón Jiménez","Huelva","21005",{"type":46,"coordinates":65},[66,67],-6.94004,37.26638,{"lat":67,"lon":66},{"facility":70,"status":40,"city":71,"state":23,"zip":72,"country":43,"countryCode":44,"cosmosGeoPoint":73,"geoPoint":77,"contacts":23},"Hospital Universitario de Leon","León","24008",{"type":46,"coordinates":74},[75,76],-5.57032,42.60003,{"lat":76,"lon":75},{"facility":79,"status":40,"city":80,"state":23,"zip":81,"country":43,"countryCode":44,"cosmosGeoPoint":82,"geoPoint":86,"contacts":23},"Hospital Universitario Lucus Augusti","Lugo","270003",{"type":46,"coordinates":83},[84,85],-7.55602,43.00992,{"lat":85,"lon":84},{"facility":88,"status":40,"city":89,"state":23,"zip":90,"country":43,"countryCode":44,"cosmosGeoPoint":91,"geoPoint":95,"contacts":23},"Hospital Universitario Central de Asturias","Oviedo","33011",{"type":46,"coordinates":92},[93,94],-5.84476,43.36029,{"lat":94,"lon":93},{"facility":97,"status":40,"city":98,"state":23,"zip":99,"country":43,"countryCode":44,"cosmosGeoPoint":100,"geoPoint":104,"contacts":23},"Hospital Provincial de Pontevedra","Pontevedra","36071",{"type":46,"coordinates":101},[102,103],-8.64435,42.431,{"lat":103,"lon":102},{"type":106,"investigatorFullName":23,"investigatorTitle":23,"investigatorAffiliation":23,"oldNameTitle":23,"oldOrganization":23},"SPONSOR","100550558","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-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":117,"type":118},94,"ESTIMATED","INTERVENTIONAL",[121],"NA","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",[124],"Coronary Artery Disease",[126,127],"Drug-coated balloon","Vasomotor function","2026-03-20",{"date":130,"type":131},"2026-03-23","ACTUAL",{"date":133,"type":131},"2024-10-23",{"date":135,"type":118},"2027-05-01",{"name":5,"class":6},7]