[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588038":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":12,"locations":18,"responsibleParty":34,"collaborators":10,"id":36,"slug":37,"hasResults":38,"nctId":39,"briefTitle":40,"officialTitle":41,"acronym":10,"eligibilityCriteria":42,"healthyVolunteers":38,"sex":43,"minAge":44,"maxAge":45,"enrollmentInfo":46,"targetDuration":10,"studyType":49,"phases":10,"briefSummary":50,"conditions":51,"keywords":10,"overallStatus":21,"whyStopped":10,"lastUpdateSubmitDate":53,"lastUpdatePostDateStruct":54,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},{"fullName":5,"class":6},"Shanghai Bluesail Boyuan Medical Technology Co., Ltd.","INDUSTRY",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Calcified Carotid Artery Stenosis Treated with IVL and Carotid Artery Stenting (CAS)",null,"All patients participating in this extended follow-up period are sourced from the registered clinical trial.",[13],{"name":14,"role":15,"phone":16,"phoneExt":10,"email":17},"Xiaochuan Huo","CONTACT","010-64412431","huoxiaochuan@126.com",[19],{"facility":20,"status":21,"city":22,"state":10,"zip":10,"country":23,"countryCode":24,"cosmosGeoPoint":25,"geoPoint":30,"contacts":31},"Beijing Anzhen Hospital","RECRUITING","Beijing","China","CN",{"type":26,"coordinates":27},"Point",[28,29],116.39723,39.9075,{"lat":29,"lon":28},[32],{"name":14,"role":15,"phone":33,"phoneExt":10,"email":17},"010-84005400",{"type":35,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100588038","prospective-trial-of-ivl-for-calcified-carotid-lesionscreate-trialextended-follow-up-100588038",false,"NCT06936189","Prospective Trial of IVL for Calcified Carotid Lesions(CREATE Trial)(Extended Follow-Up)","A Prospective, Multicenter, Single-Arm Objective Performance Criteria Clinical Trial Evaluating the Safety and Efficacy of a Single-Use Neurovascular Intravascular Shockwave Catheter and Intravascular Shockwave Therapy Device for Pretreatment of Calcified Lesions in the Extracranial Carotid Artery (CREATE Trial)） (Extended Follow-Up)","Inclusion criteria:\n\nAll patients participating in this extended follow-up period are sourced from the registered clinical trial.\n\nExclusion criteria:\n\nnone","ALL","18 Years","80 Years",{"count":47,"type":48},204,"ESTIMATED","OBSERVATIONAL","Purpose: To assess the long-term safety and efficacy of the intravascular lithotripsy system for pre-treatment of calcified carotid artery stenosis.\n\nDesign: Prospective, multicenter, single-arm study with an extended follow-up period.\n\nSample Size: 204 participants (based on the final number of cases enrolled in the registration trial).\n\nEndpoints:\n\nPrimary: Surgical success rate (residual stenosis \\\u003C30% after stenting). Secondary: Target lesion re-narrowing rate, target lesion revascularization rate, MAE rate, ipsilateral stroke rate, and MACCE rate at 3 and 6 months postoperatively.\n\nFollow-Up: Participants will be followed up at 3 months ±15 days and 6 months ±30 days postoperatively.\n\nInclusion criteria:\n\nAll patients participating in this extended follow-up period are sourced from the registered clinical trial.\n\nEthics and Consent: The trial will be conducted in accordance with the Helsinki Declaration and Chinese regulations. Informed consent will be obtained from all participants or their legal guardians.\n\nSponsor: Shanghai Lanfan Boyuan Medical Technology Co., Ltd. Principal Investigator: Professor Huo Xiaochuan, Beijing Anzhen Hospital.",[52],"Carotid Artery Stenosis","2025-05-13",{"date":55,"type":56},"2025-05-16","ACTUAL",{"date":58,"type":56},"2025-05-12",{"date":60,"type":48},"2027-12-30",{"name":5,"class":6},1]