[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100478127":3},{"organization":4,"outcomesModule":7,"designInfo":24,"detailedDescription":27,"studyPopulation":28,"armGroups":11,"interventions":29,"overallOfficials":11,"centralContacts":34,"locations":40,"responsibleParty":169,"collaborators":171,"id":175,"slug":11,"hasResults":176,"nctId":177,"briefTitle":178,"officialTitle":179,"acronym":11,"eligibilityCriteria":180,"healthyVolunteers":176,"sex":181,"minAge":182,"maxAge":11,"enrollmentInfo":183,"targetDuration":186,"studyType":187,"phases":11,"briefSummary":188,"conditions":189,"keywords":191,"overallStatus":43,"whyStopped":11,"lastUpdateSubmitDate":195,"lastUpdatePostDateStruct":196,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":204},{"fullName":5,"class":6},"Biosensors Europe SA","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Target Lesion Failure (TLF)",null,"12 months",[14,16,18,20,22],{"measure":15,"description":11,"timeFrame":12},"Clinically driven Target Lesion Revascularization (TLR)",{"measure":17,"description":11,"timeFrame":12},"Cardiovascular death (CD)",{"measure":19,"description":11,"timeFrame":12},"Target Vessel MI",{"measure":21,"description":11,"timeFrame":12},"Target Vessel Revascularization (TVR)",{"measure":23,"description":11,"timeFrame":12},"Stent thrombosis",{"allocation":11,"interventionModel":11,"interventionModelDescription":11,"primaryPurpose":11,"observationalModel":25,"timePerspective":26,"maskingInfo":11},"COHORT","PROSPECTIVE","Prospective, observational multi-center registry to be conducted at up to 150 interventional cardiology centers in up to 15 countries. Patients will be followed by telephone for 1 year after PCI for data collection. This registry captures data on BioFreedomTM Ultra CoCr DCS in standard clinical practice (real world population) and serves as Post-Market Surveillance.\n\nThis registry will enroll up to 10000 patients in up to 150 investigative centers in Europe, South America, Middle East, Asia over a period of 5 years. Each patient be followed with phone (or clinic) visit at 12 months.","This observational registry is open to all patients with coronary artery disease treated by percutaneous coronary intervention (PCI) with one or more BioFreedom™ Ultra CoCr DCS within the products indications of the Instructions for Use (IFU).",[30],{"type":31,"name":32,"description":33,"armGroupLabels":11,"otherNames":11},"DEVICE","Biofreedom Ultra","The BioFreedomTM Ultra CoCr DCS is a combination product consisting of two key components: the cobalt chromium stent platform coated abluminally with the active ingredient BA9TM (polymer and carrier free) and the delivery system.",[35],{"name":36,"role":37,"phone":38,"phoneExt":11,"email":39},"Calvin Bahr, MS","CONTACT","+41 21 804 80 24","c.bahr@biosensors.com",[41,56,69,82,95,108,119,132,145,158],{"facility":42,"status":43,"city":44,"state":11,"zip":11,"country":45,"countryCode":46,"cosmosGeoPoint":47,"geoPoint":52,"contacts":53},"Krankenhaus Barmherzige Brüder","RECRUITING","Eisenstadt","Austria","AT",{"type":48,"coordinates":49},"Point",[50,51],16.52327,47.84565,{"lat":51,"lon":50},[54],{"name":55,"role":37,"phone":11,"phoneExt":11,"email":11},"Rudolf Berger, Prof.",{"facility":57,"status":43,"city":58,"state":11,"zip":11,"country":59,"countryCode":60,"cosmosGeoPoint":61,"geoPoint":65,"contacts":66},"Clinique Des Domes Psr","Clermont-Ferrand","France","FR",{"type":48,"coordinates":62},[63,64],3.08682,45.77969,{"lat":64,"lon":63},[67],{"name":68,"role":37,"phone":11,"phoneExt":11,"email":11},"Janusz Lipiecki, MD",{"facility":70,"status":43,"city":71,"state":11,"zip":11,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":78,"contacts":79},"Klinikum Lippe","Detmold","Germany","DE",{"type":48,"coordinates":75},[76,77],8.87318,51.93855,{"lat":77,"lon":76},[80],{"name":81,"role":37,"phone":11,"phoneExt":11,"email":11},"Stephan Gielen, Prof",{"facility":83,"status":43,"city":84,"state":11,"zip":11,"country":85,"countryCode":86,"cosmosGeoPoint":87,"geoPoint":91,"contacts":92},"Hospital Marques Valdecilla","Santander","Spain","ES",{"type":48,"coordinates":88},[89,90],-3.80493,43.46589,{"lat":90,"lon":89},[93],{"name":94,"role":37,"phone":11,"phoneExt":11,"email":11},"José Maria de La Torre Hernández, MD",{"facility":96,"status":43,"city":97,"state":11,"zip":11,"country":98,"countryCode":99,"cosmosGeoPoint":100,"geoPoint":104,"contacts":105},"University and Hospital Fribourg","Fribourg","Switzerland","CH",{"type":48,"coordinates":101},[102,103],7.15128,46.80237,{"lat":103,"lon":102},[106],{"name":107,"role":37,"phone":11,"phoneExt":11,"email":11},"Stéphane Cook, Prof",{"facility":109,"status":43,"city":110,"state":11,"zip":11,"country":98,"countryCode":99,"cosmosGeoPoint":111,"geoPoint":115,"contacts":116},"Universitäres Herzzentrum","Zurich",{"type":48,"coordinates":112},[113,114],8.55,47.36667,{"lat":114,"lon":113},[117],{"name":118,"role":37,"phone":11,"phoneExt":11,"email":11},"Barbara Stähli, Prof",{"facility":120,"status":43,"city":121,"state":11,"zip":11,"country":122,"countryCode":123,"cosmosGeoPoint":124,"geoPoint":128,"contacts":129},"Military hospital","Tunis","Tunisia","TN",{"type":48,"coordinates":125},[126,127],10.16579,36.81897,{"lat":127,"lon":126},[130],{"name":131,"role":37,"phone":11,"phoneExt":11,"email":11},"Nahdem Hajlaoui, Prof",{"facility":133,"status":43,"city":134,"state":11,"zip":11,"country":135,"countryCode":136,"cosmosGeoPoint":137,"geoPoint":141,"contacts":142},"Al Qassimi Hospital","Sharjah city","United Arab Emirates","AE",{"type":48,"coordinates":138},[139,140],55.41221,25.3342,{"lat":140,"lon":139},[143],{"name":144,"role":37,"phone":11,"phoneExt":11,"email":11},"Arif Al Nooryani, MD",{"facility":146,"status":43,"city":147,"state":11,"zip":11,"country":148,"countryCode":149,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"Royal Bournemouth hospital","Bournemouth","United Kingdom","UK",{"type":48,"coordinates":151},[152,153],-1.8795,50.72048,{"lat":153,"lon":152},[156],{"name":157,"role":37,"phone":11,"phoneExt":11,"email":11},"Peter O'Kane, MD",{"facility":159,"status":43,"city":160,"state":11,"zip":11,"country":148,"countryCode":149,"cosmosGeoPoint":161,"geoPoint":165,"contacts":166},"Golden Jubilee National Hospital","Glasgow",{"type":48,"coordinates":162},[163,164],-4.25763,55.86515,{"lat":164,"lon":163},[167],{"name":168,"role":37,"phone":11,"phoneExt":11,"email":11},"Stuart Watkins, MD",{"type":170,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[172],{"name":173,"class":174},"European Cardiovascular Research Center","NETWORK","100478127",false,"NCT05505929","eUltra 10k - Biofreedom Ultra","A Post-Market Registry of the BioFreedom Ultra CoCr Biolimus A9 Coated Coronary Stent System","Inclusion Criteria:\n\n* According to the current version of Instructions of Use (IFU)\n* Patient is at least 18 years old\n* Patient provides a signed informed consent\n\nExclusion Criteria:\n\n* According to current version of IFU\n* Patients will be excluded as per Medical Device Regulation (MDR) (Article 65: \"Clinical investigations on minors\" and article 66: \"Clinical investigations on pregnant or breastfeeding women\"\n* Patients will be excluded if they are under judicial protection, guardianship or curatorship or if they are deprived of their liberty by judicial or administrative decision","ALL","18 Years",{"count":184,"type":185},10000,"ESTIMATED","12 Months","OBSERVATIONAL","This registry captures data on BioFreedomTM Ultra CoCr DCS in standard clinical practice (real world population) and serves as Post Market Clinical Follow up (PMCF) as part of the Post-Market Surveillance.",[190],"Post Market Clinical Follow up (PMCF)",[192,193,32,194],"PMCF","Registry","eUltra","2026-03-02",{"date":197,"type":198},"2026-03-04","ACTUAL",{"date":200,"type":198},"2023-06-15",{"date":202,"type":185},"2029-03-30",{"name":5,"class":6},10]