[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572717":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":28,"locations":38,"responsibleParty":112,"collaborators":11,"id":114,"slug":115,"hasResults":116,"nctId":117,"briefTitle":118,"officialTitle":119,"acronym":120,"eligibilityCriteria":121,"healthyVolunteers":116,"sex":122,"minAge":123,"maxAge":11,"enrollmentInfo":124,"targetDuration":11,"studyType":127,"phases":128,"briefSummary":130,"conditions":131,"keywords":134,"overallStatus":41,"whyStopped":11,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":147},{"fullName":5,"class":6},"Fundación EPIC","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Balloon Angioplasty (BA)","ACTIVE_COMPARATOR",null,[13],"Device: Balloon System Treatment",{"label":15,"type":10,"description":11,"interventionNames":16},"Orbital Atherectomy (OA)",[17],"Device: Orbital Atherectomy System Treatment",[19,24],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"DEVICE","Orbital Atherectomy System Treatment","Percutaneous coronary intervention of a calcified bifurcation coronary lesion with balloon angioplasty followed by drug eluting stent. Selection of balloon type is at operator´s discretion. Baseline and post dilation OCT will be performed.",[15],{"type":20,"name":25,"description":26,"armGroupLabels":27,"otherNames":11},"Balloon System Treatment","Percutaneous coronary intervention of a calcified bifurcation coronary lesion with Orbital Atherectomy followed by drug eluting stent. Baseline and post dilation OCT will be performed.",[9],[29,34],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"JORGE PALAZUELOS, MD, PhD","CONTACT","0034659768506","jpalaz@gmail.com",{"name":35,"role":31,"phone":36,"phoneExt":11,"email":37},"FUNDACION EPIC","0034987876135","iepic@fundacionepic.org",[39,52,61,67,76,85,94,103],{"facility":40,"status":41,"city":42,"state":11,"zip":43,"country":44,"countryCode":45,"cosmosGeoPoint":46,"geoPoint":51,"contacts":11},"H. G.U. de ALICANTE DR. BALMIS","RECRUITING","Alicante","03010","Spain","ES",{"type":47,"coordinates":48},"Point",[49,50],-0.48149,38.34517,{"lat":50,"lon":49},{"facility":53,"status":41,"city":54,"state":11,"zip":55,"country":44,"countryCode":45,"cosmosGeoPoint":56,"geoPoint":60,"contacts":11},"Hospital Del Mar","Barcelona","08003",{"type":47,"coordinates":57},[58,59],2.15899,41.38879,{"lat":59,"lon":58},{"facility":62,"status":41,"city":54,"state":11,"zip":63,"country":44,"countryCode":45,"cosmosGeoPoint":64,"geoPoint":66,"contacts":11},"H. de La Santa Creu I Sant Pau","08041",{"type":47,"coordinates":65},[58,59],{"lat":59,"lon":58},{"facility":68,"status":41,"city":69,"state":11,"zip":70,"country":44,"countryCode":45,"cosmosGeoPoint":71,"geoPoint":75,"contacts":11},"Hospital Universitario Reina Sofia","Córdoba","14004",{"type":47,"coordinates":72},[73,74],-4.77275,37.89155,{"lat":74,"lon":73},{"facility":77,"status":41,"city":78,"state":11,"zip":79,"country":44,"countryCode":45,"cosmosGeoPoint":80,"geoPoint":84,"contacts":11},"Hospital Universitario La Paz","Fuencarral-El Pardo","28046",{"type":47,"coordinates":81},[82,83],-3.7314,40.4984,{"lat":83,"lon":82},{"facility":86,"status":41,"city":87,"state":11,"zip":88,"country":44,"countryCode":45,"cosmosGeoPoint":89,"geoPoint":93,"contacts":11},"Hospital Universitario Lucus Augusti","Lugo","270003",{"type":47,"coordinates":90},[91,92],-7.55602,43.00992,{"lat":92,"lon":91},{"facility":95,"status":41,"city":96,"state":11,"zip":97,"country":44,"countryCode":45,"cosmosGeoPoint":98,"geoPoint":102,"contacts":11},"Hospital Universitario La Luz","Madrid","28003",{"type":47,"coordinates":99},[100,101],-3.70256,40.4165,{"lat":101,"lon":100},{"facility":104,"status":41,"city":105,"state":11,"zip":106,"country":44,"countryCode":45,"cosmosGeoPoint":107,"geoPoint":111,"contacts":11},"Hospital Universitario Virgen del Rocio","Seville","41013",{"type":47,"coordinates":108},[109,110],-5.97317,37.38283,{"lat":110,"lon":109},{"type":113,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","100572717","trial-of-orbital-atherectomy-versus-standard-strategy-in-calcified-bifurcation-lesions-100572717",false,"NCT06736899","Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions","Randomized Trial of Orbital Atherectomy Versus Standard Strategy in Calcified Bifurcation Lesions","OraBil","Inclusion Criteria:\n\n* Patients over 18 years of age and\n* Patients with moderately or severely calcified bifurcation lesions (lateral vessel ≥ 2mm), candidates for PCI with coronary stent implantation, in whom there is the possibility of adequate clinical follow-up at 1 year and\n* Patients agree to participate in the study, by signing the Informed Consent.\n\nExclusion Criteria:\n\n* Patients with revascularization of the artery to be treated within 9 months prior to the index procedure.\n* Patients with contraindication for the use of Orbital Atherectomy:\n\n  * Patients in cardiogenic shock.\n  * Patients with Thrombotic lesions.\n  * Patients with Vascular graft disease.\n  * Patients with remain vessel disease.\n  * Patients with severe left ventricular dysfunction.\n  * Patients allergic to the components of the washing serum (glide).\n* Patients with life expectancy less than one year.","ALL","18 Years",{"count":125,"type":126},200,"ESTIMATED","INTERVENTIONAL",[129],"NA","Clinical research with medical devices indicated in accordance with the CE marking, led by researchers, multicenter, open, prospective, randomized and controlled. Patients are randomized to treatment with a conventional balloon and then a coronary stent or to initial plaque modification with Orbital Atherectomy (OA) and then a coronary stent. To evaluate the efficacy and safety of OA in the adequate treatment with coronary stent of the calcified bifurcation lesion using angiography and optical coherence tomography (OCT).",[132,133],"Coronary Artery Disease","Coronary Disease",[15,135,136,137],"Percutaneous Coronary Intervention","Bifurcation","Side Branch Treatment: Mid-term results","2026-04-30",{"date":140,"type":141},"2026-05-01","ACTUAL",{"date":143,"type":141},"2025-10-23",{"date":145,"type":126},"2026-12-31",{"name":5,"class":6},8]