[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100572717":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":11,"centralContacts":28,"locations":38,"responsibleParty":111,"collaborators":11,"id":113,"slug":11,"hasResults":114,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":114,"sex":120,"minAge":121,"maxAge":11,"enrollmentInfo":122,"targetDuration":11,"studyType":125,"phases":126,"briefSummary":128,"conditions":129,"keywords":132,"overallStatus":41,"whyStopped":11,"lastUpdateSubmitDate":136,"lastUpdatePostDateStruct":137,"startDateStruct":140,"completionDateStruct":142,"leadSponsor":144,"locationsCount":145},{"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",[39,51,60,66,75,84,93,102],{"facility":40,"status":41,"city":42,"state":11,"zip":43,"country":44,"cosmosGeoPoint":45,"geoPoint":50,"contacts":11},"H. G.U. de ALICANTE DR. BALMIS","RECRUITING","Alicante","03010","Spain",{"type":46,"coordinates":47},"Point",[48,49],-0.48149,38.34517,{"lat":49,"lon":48},{"facility":52,"status":41,"city":53,"state":11,"zip":54,"country":44,"cosmosGeoPoint":55,"geoPoint":59,"contacts":11},"Hospital Del Mar","Barcelona","08003",{"type":46,"coordinates":56},[57,58],2.15899,41.38879,{"lat":58,"lon":57},{"facility":61,"status":41,"city":53,"state":11,"zip":62,"country":44,"cosmosGeoPoint":63,"geoPoint":65,"contacts":11},"H. de La Santa Creu I Sant Pau","08041",{"type":46,"coordinates":64},[57,58],{"lat":58,"lon":57},{"facility":67,"status":41,"city":68,"state":11,"zip":69,"country":44,"cosmosGeoPoint":70,"geoPoint":74,"contacts":11},"Hospital Universitario Reina Sofia","Córdoba","14004",{"type":46,"coordinates":71},[72,73],-4.77275,37.89155,{"lat":73,"lon":72},{"facility":76,"status":41,"city":77,"state":11,"zip":78,"country":44,"cosmosGeoPoint":79,"geoPoint":83,"contacts":11},"Hospital Universitario La Paz","Fuencarral-El Pardo","28046",{"type":46,"coordinates":80},[81,82],-3.7314,40.4984,{"lat":82,"lon":81},{"facility":85,"status":41,"city":86,"state":11,"zip":87,"country":44,"cosmosGeoPoint":88,"geoPoint":92,"contacts":11},"Hospital Universitario Lucus Augusti","Lugo","270003",{"type":46,"coordinates":89},[90,91],-7.55602,43.00992,{"lat":91,"lon":90},{"facility":94,"status":41,"city":95,"state":11,"zip":96,"country":44,"cosmosGeoPoint":97,"geoPoint":101,"contacts":11},"Hospital Universitario La Luz","Madrid","28003",{"type":46,"coordinates":98},[99,100],-3.70256,40.4165,{"lat":100,"lon":99},{"facility":103,"status":41,"city":104,"state":11,"zip":105,"country":44,"cosmosGeoPoint":106,"geoPoint":110,"contacts":11},"Hospital Universitario Virgen del Rocio","Seville","41013",{"type":46,"coordinates":107},[108,109],-5.97317,37.38283,{"lat":109,"lon":108},{"type":112,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR","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":123,"type":124},200,"ESTIMATED","INTERVENTIONAL",[127],"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).",[130,131],"Coronary Artery Disease","Coronary Disease",[15,133,134,135],"Percutaneous Coronary Intervention","Bifurcation","Side Branch Treatment: Mid-term results","2026-04-30",{"date":138,"type":139},"2026-05-01","ACTUAL",{"date":141,"type":139},"2025-10-23",{"date":143,"type":124},"2026-12-31",{"name":5,"class":6},8]