[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100623620":3},{"organization":4,"outcomesModule":7,"designInfo":75,"detailedDescription":78,"studyPopulation":79,"armGroups":80,"interventions":85,"overallOfficials":74,"centralContacts":91,"locations":101,"responsibleParty":192,"collaborators":74,"id":194,"slug":195,"hasResults":196,"nctId":197,"briefTitle":198,"officialTitle":199,"acronym":88,"eligibilityCriteria":200,"healthyVolunteers":196,"sex":201,"minAge":202,"maxAge":74,"enrollmentInfo":203,"targetDuration":63,"studyType":206,"phases":74,"briefSummary":207,"conditions":208,"keywords":211,"overallStatus":104,"whyStopped":74,"lastUpdateSubmitDate":214,"lastUpdatePostDateStruct":215,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":223},{"fullName":5,"class":6},"Fundación EPIC","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":74},[9],{"measure":10,"description":11,"timeFrame":12},"Target Lesion Failure (TLF)","Target Lesion Failure defined as the composite of cardiovascular death, target-vessel related myocardial infarction and clinically driven target lesion revascularization at 1-year post-procedure.","1 year",[14,18,21,24,27,30,33,36,39,42,45,48,51,54,57,59,62,64,68,71],{"measure":15,"description":16,"timeFrame":17},"Device success","Device success defined as delivery success (achievement of successful delivery of study stent to the target lesion, expansion of the study stent and withdrawal of the delivery catheter) with a final residual diameter stenosis of the target lesion of \\\u003C 20% by visual assessment and\u002For \\\u003C 30% by QCA, using the assigned device only.","Periprocedural",{"measure":19,"description":20,"timeFrame":17},"Safety of the stent: Freedom from Accidental dislodgement of the stent","Safety of the stent defined as an absence of Accidental stent dislodgement",{"measure":22,"description":23,"timeFrame":17},"Safety of the stent: Freedom from Balloon rupture","Safety of the stent defined as an absence of Balloon rupture o Hypotube rupture.",{"measure":25,"description":26,"timeFrame":17},"Safety of the stent: Freedom from Hypotube rupture o Hypotube rupture","Safety of the stent defined as an absence of o Hypotube rupture o Hypotube rupture.",{"measure":28,"description":29,"timeFrame":17},"Safety of the procedure: Freedom from Challenging withdrawal","Safety of the procedure defined as an absence of Challenging withdrawal",{"measure":31,"description":32,"timeFrame":17},"Safety of the procedure: Freedom from coronary perforation","Safety of the procedure defined as an absence of coronary perforation",{"measure":34,"description":35,"timeFrame":17},"Safety of the procedure: Freedom from dissection >C","Safety of the procedure defined as an absence of dissection \\>C",{"measure":37,"description":38,"timeFrame":17},"Safety of the procedure: Freedom from no-reflow","Safety of the procedure defined as an absence of no-reflow",{"measure":40,"description":41,"timeFrame":17},"Safety of the procedure: Freedom from stent thrombosis","Safety of the procedure defined as an absence stent thrombosis",{"measure":43,"description":44,"timeFrame":17},"Procedure success","To assess the procedure success rate defined as the achievement of \\\u003C 20% residual stenosis by visual assessment in all target lesions using any percutaneous method without the occurrence of death, Q wave or WHO defined non-Q wave myocardial Infarction, or need for new revascularization of the target lesion during the hospital stay.",{"measure":46,"description":47,"timeFrame":17},"Performance of the Ultimaster Nagomi™ stent in Severe calcified lesions","To assess Performance of the Ultimaster Nagomi™ stent in Severe calcified lesions",{"measure":49,"description":50,"timeFrame":17},"Performance of the Ultimaster Nagomi™ stent in Severe tortuous vessels","To assess Performance of the Ultimaster Nagomi™ stent in Severe tortuous vessels",{"measure":52,"description":53,"timeFrame":17},"Performance of the Ultimaster Nagomi™ stent in Distal vessels","To assess Performance of the Ultimaster Nagomi™ stent in Distal vessels",{"measure":55,"description":55,"timeFrame":56},"Angina status assessment Seattle Angina Questionnaire (SAQ)","Baseline",{"measure":55,"description":55,"timeFrame":58},"12 monts",{"measure":60,"description":60,"timeFrame":61},"Quality of Life assessed as per EuroQl five-dimensional (EQ-5D) questionnaire","After PCI",{"measure":60,"description":60,"timeFrame":63},"12 Months",{"measure":65,"description":66,"timeFrame":67},"Cardiovascular death","Percentage of cardiovascular death","12 months",{"measure":69,"description":70,"timeFrame":63},"Target-vessel related myocardial infarction","Percentage of target-vessel related myocardial infarction",{"measure":72,"description":73,"timeFrame":67},"Clinically driven target lesion revascularization","Percentage of clinically driven target lesion revascularization",null,{"allocation":74,"interventionModel":74,"interventionModelDescription":74,"primaryPurpose":74,"observationalModel":76,"timePerspective":77,"maskingInfo":74},"CASE_ONLY","PROSPECTIVE","The study serves to fulfill post marketing surveillance requirements for the Ultimaster Nagomi™ stent. This is a PMCF study of real-world use of the Ultimaster Nagomi™ DES aimed to reaffirm the device claims of effectiveness and safety, no comparator is required to meet these specified objectives and endpoints.","Patients undergoing PCI with implantation of a Long Nagomi stent",[81],{"label":82,"type":74,"description":74,"interventionNames":83},"Coronary Artery Disease (CAD)",[84],"Device: LONG NAGOMI",[86],{"type":87,"name":88,"description":89,"armGroupLabels":90,"otherNames":74},"DEVICE","LONG NAGOMI","Patients in whom treatment with long nagomi has been attempted",[82],[92,97],{"name":93,"role":94,"phone":95,"phoneExt":74,"email":96},"TAMARA GARCIA CAMARERO, MD, PhD","CONTACT","0034615420460","tgcamarero@gmail.com",{"name":98,"role":94,"phone":99,"phoneExt":74,"email":100},"FUNDACION EPIC","00987876135","iepic@fundacionepic.org",[102,115,124,133,142,151,160,165,174,183],{"facility":103,"status":104,"city":105,"state":74,"zip":106,"country":107,"countryCode":108,"cosmosGeoPoint":109,"geoPoint":114,"contacts":74},"Hospital Universitario de Cabueñes","RECRUITING","Cabueñes","33394","Spain","ES",{"type":110,"coordinates":111},"Point",[112,113],-5.60569,43.52347,{"lat":113,"lon":112},{"facility":116,"status":104,"city":117,"state":74,"zip":118,"country":107,"countryCode":108,"cosmosGeoPoint":119,"geoPoint":123,"contacts":74},"Hospital General Universitario de Ciudad Real","Ciudad Real","13005",{"type":110,"coordinates":120},[121,122],-3.92907,38.98626,{"lat":122,"lon":121},{"facility":125,"status":104,"city":126,"state":74,"zip":127,"country":107,"countryCode":108,"cosmosGeoPoint":128,"geoPoint":132,"contacts":74},"Hospital General Universitario de Elche","Elche","03203",{"type":110,"coordinates":129},[130,131],-0.70107,38.26218,{"lat":131,"lon":130},{"facility":134,"status":104,"city":135,"state":74,"zip":136,"country":107,"countryCode":108,"cosmosGeoPoint":137,"geoPoint":141,"contacts":74},"Hospital Universitario Juan Ramón Jiménez","Huelva","21005",{"type":110,"coordinates":138},[139,140],-6.94004,37.26638,{"lat":140,"lon":139},{"facility":143,"status":104,"city":144,"state":74,"zip":145,"country":107,"countryCode":108,"cosmosGeoPoint":146,"geoPoint":150,"contacts":74},"Hospital Universitario de Leon","León","24008",{"type":110,"coordinates":147},[148,149],-5.57032,42.60003,{"lat":149,"lon":148},{"facility":152,"status":104,"city":153,"state":74,"zip":154,"country":107,"countryCode":108,"cosmosGeoPoint":155,"geoPoint":159,"contacts":74},"Hospital Universitario Regional de Málaga","Málaga","29010",{"type":110,"coordinates":156},[157,158],-4.42034,36.72016,{"lat":158,"lon":157},{"facility":161,"status":104,"city":153,"state":74,"zip":154,"country":107,"countryCode":108,"cosmosGeoPoint":162,"geoPoint":164,"contacts":74},"Hospital Universitario Virgen de la Victoria",{"type":110,"coordinates":163},[157,158],{"lat":158,"lon":157},{"facility":166,"status":104,"city":167,"state":74,"zip":168,"country":107,"countryCode":108,"cosmosGeoPoint":169,"geoPoint":173,"contacts":74},"Hospital Universitario de Navarra","Pamplona","31008",{"type":110,"coordinates":170},[171,172],-1.64323,42.81687,{"lat":172,"lon":171},{"facility":175,"status":104,"city":176,"state":74,"zip":177,"country":107,"countryCode":108,"cosmosGeoPoint":178,"geoPoint":182,"contacts":74},"Hospital Universitario Marqués de Valdecilla","Santander","39008",{"type":110,"coordinates":179},[180,181],-3.80493,43.46589,{"lat":181,"lon":180},{"facility":184,"status":104,"city":185,"state":74,"zip":186,"country":107,"countryCode":108,"cosmosGeoPoint":187,"geoPoint":191,"contacts":74},"Hospital Universitario Virgen del Rocio","Seville","41013",{"type":110,"coordinates":188},[189,190],-5.97317,37.38283,{"lat":190,"lon":189},{"type":193,"investigatorFullName":74,"investigatorTitle":74,"investigatorAffiliation":74,"oldNameTitle":74,"oldOrganization":74},"SPONSOR","100623620","long-nagomi-pmcf-study-100623620",false,"NCT07399002","LONG NAGOMI™ PMCF STUDY","Long Coronary Lesions: Safety and Performance of the Ultimaster Nagomi™ Stent in This Setting With a One-to-one Approach -One Lesion, One Stent- LONG NAGOMI™ PMCF STUDY","Inclusion Criteria:\n\n* Patients who meet ALL inclusion criteria will be included:\n* Patients aged ≥ 18 years AND;\n* Patients who according to standard practice of the hospital are amenable to PCI as indicated and considered adequate according to the European clinical practice guidelines on coronary revascularization AND;\n* Patients with at least one lesion fulfilling the \"long lesion criteria\" suitable for a single stent approach AND;\n* Patients who have been informed of the characteristics of the study and have provided written informed consent AND;\n* Intention to treat all lesions with the Ultimaster Nagomi™ stent\n\nExclusion Criteria:\n\n* Patients must not meet any of the following exclusion criteria:\n* Patients who expressly decline to participate in the study.\n* Pregnant or breastfeeding women.\n* Patients with acute coronary syndrome (ACS) under conditions of cardiogenic shock (Killip class 4).\n* Patients with contraindications or hypersensitivity to sirolimus.\n* Patients with a life expectancy of less than 2 years.\n* Patients in whom any surgery requiring general anesthesia is planned, comorbidity or indication likely necessitating the discontinuation of dual anti-platelet therapy before the recommended duration of dual anti-platelet therapy per the ESC or national guidelines.\n* Patients included in other clinical trials that did not reach the primary objective.","ALL","18 Years",{"count":204,"type":205},1039,"ESTIMATED","OBSERVATIONAL","The study is designed as a prospective, multi-center, observational PMCF (post-market clinical follow-up) study of the Ultimaster Nagomi™ \\_stent (lengths of 38, 44 and 50 mm) in the treatment of coronary artery disease according to the indications approved in the CE marking.",[209,210],"Coronary Artery Disease","Ischemic Heart Disease",[212,213],"MDR (Medical Device Regulations)","PMCF (Post-Market Clinical Follow-up)","2026-09-10",{"date":216,"type":217},"2026-09-11","ACTUAL",{"date":219,"type":217},"2026-02-27",{"date":221,"type":205},"2029-01-01",{"name":5,"class":6},10]