[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100613743":3},{"organization":4,"armGroups":7,"interventions":14,"overallOfficials":23,"centralContacts":37,"locations":10,"responsibleParty":46,"collaborators":48,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":10,"enrollmentInfo":61,"targetDuration":10,"studyType":64,"phases":10,"briefSummary":65,"conditions":66,"keywords":69,"overallStatus":82,"whyStopped":10,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":87,"completionDateStruct":89,"leadSponsor":91,"locationsCount":10},{"fullName":5,"class":6},"Cardiovascular and Interventional Radiological Society of Europe","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Adult CLTI patients with femoropopliteal or infrapopliteal calcified lesions",null,"Eligible patients are those who will undergo OA prior to any adjunctive endovascular procedure",[13],"Device: Stealth 360™ Peripheral Orbital Atherectomy System from Abbott",[15],{"type":16,"name":17,"description":18,"armGroupLabels":19,"otherNames":20},"DEVICE","Stealth 360™ Peripheral Orbital Atherectomy System from Abbott","The Stealth 360™ Peripheral Orbital Atherectomy System uses a diamond-coated, eccentrically mounted crown with bi-directional capabilities that treat a wide range of vessels, enabling single device treatment of multiple lesions and vessel sizes.",[9],[21,22],"Orbital Atherectomy","Orbital Atherectomy System",[24,28,31,34],{"name":25,"affiliation":26,"role":27},"Gerd Grözinger, Prof. Dr. med.","SLK Kliniken Heilbronn GmbH","STUDY_CHAIR",{"name":29,"affiliation":30,"role":27},"Marianne Brodmann, Univ.-Prof. Dr. med.","Medizinische Universität Graz",{"name":32,"affiliation":33,"role":27},"Raghu Lakshminarayan, Dr","Hull University Teaching Hospitals NHS Trust",{"name":35,"affiliation":36,"role":27},"Stefan Müller-Hülsbeck, Prof. Dr. med.","DIAKO Krankenhaus gGmBH",[38,43],{"name":39,"role":40,"phone":41,"phoneExt":10,"email":42},"Claire Poulet, PhD","CONTACT","+41 79 385 16 78","oracue@cirse.org",{"name":44,"role":40,"phone":45,"phoneExt":10,"email":42},"Dhwani S. Korde, PhD","+4367762942469",{"type":47,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR",[49],{"name":50,"class":51},"Abbott","INDUSTRY","100613743","orbital-atherectomy-for-lesion-preparation-in-patients-with-chronic-limb-threatening-ischemia-100613743",false,"NCT07270562","ORbital Atherectomy for Lesion Preparation in Patients With Chronic Limb-threatening ischEmia","ORACLE","Inclusion Criteria:\n\n1. Rutherford classification category ≥4;\n2. Treatment of femoropopliteal or infrapopliteal calcified lesions with OA using the Stealth 360 peripheral OA System;\n3. Calcification of target lesions must be visible on fluoroscopy or CT-angiography;\n4. Patients competent and willing to provide informed consent.\n\nExclusion Criteria:\n\n1. Minors and other vulnerable populations who may not be able to give informed consent freely or for whom participation is not essential to the study (incapacitated and unconscious individuals, persons deprived of liberty, pregnant and breastfeeding women, etc.);\n2. Inadequate inflow (\\>30% stenosis) following optimization;\n3. Insufficient direct outflow (less than 1 run-off vessel);\n4. Endovascular procedure(s) on the treatment site within 4 weeks before index procedure;\n5. Patients planned to receive an above ankle amputation of the target limb;\n6. Patients enrolled in RESCUE (ClinicalTrials.gov ID NCT07270575).","ALL","18 Years",{"count":62,"type":63},250,"ESTIMATED","OBSERVATIONAL","ORACLE is a Europe-wide study that will follow 250 people with critical limb-threatening ischemia (CLTI). It aims to see how well orbital atherectomy (OA) works in real-life practice. OA is a procedure that uses a tiny spinning tool to gently remove hard calcium from inside an artery, helping to open the vessel so other treatments-like balloons or stents-can work better. The study focuses on people who have heavily calcified arteries in the femoropopliteal or infrapopliteal areas of the leg.",[67,68],"Chronic Limb Threatening Ischemia","Chronic Limb-Threatening Ischemia",[70,71,72,73,74,75,76,77,78,79,80,81],"CLTI","Peripheral artery disease","Orbital atherectomy","Observational cohort study","Chronic limb ischemia","Critical limb-threatening ischemia","Calcified peripheral artery lesions","Vessel preparation","Femoropopliteal arteries","Infrapopliteal arteries","OA","Atherectomy for calcified lesions","NOT_YET_RECRUITING","2026-07-01",{"date":85,"type":86},"2026-07-02","ACTUAL",{"date":88,"type":63},"2026-08",{"date":90,"type":63},"2031-12",{"name":5,"class":6}]