protocolSection identificationModule nctId: NCT06365697, orgStudyIdInfo id: ZHTQ202301, briefTitle: Evaluation of the Ton-bridge Carotid Stent for Carotid Artery Stenosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2024-11, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-04-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Zhuhai Tonbridge Medical Tech. Co., Ltd., class: INDUSTRY, descriptionModule briefSummary: The purpose of this trial is to evaluate effectiveness and safety of the Ton-bridge carotid stent for the treatment of carotid artery stenosis., conditionsModule conditions: Carotid Artery Stenosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 188, type: ESTIMATED, armsInterventionsModule interventions name: Ton-bridge carotid stent, interventions name: WALLSTENT carotid stent, outcomesModule primaryOutcomes measure: Incidence of non-MAE(major adverse events) within 30 days post-procedure, secondaryOutcomes measure: Technical success, secondaryOutcomes measure: Procedural success, secondaryOutcomes measure: Target lesion revascularization (TLR), secondaryOutcomes measure: Ipsilateral stroke between 31 days and 1 year post-procedure, secondaryOutcomes measure: In-stent restenosis, secondaryOutcomes measure: mRS score, secondaryOutcomes measure: Device deficiency, secondaryOutcomes measure: Incidence of MAE, secondaryOutcomes measure: Incidence of Adverse events (AE), secondaryOutcomes measure: Incidence of Serious adverse events (SAE), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The People's Hospital of Liaoning Province, city: Shenyang, state: Liaoning, country: China, contacts name: Peizhuo Zang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Linyi People's Hospital, city: Linyi, state: Shandong, country: China, contacts name: Hongxing Han, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.06306, lon: 118.34278, locations facility: Qingdao Central Hospital, city: Qingdao, state: Shandong, country: China, contacts name: Haicheng Yuan, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.06488, lon: 120.38042, locations facility: The Affiliated Hospital of Qingdao University, city: Qingdao, state: Shandong, country: China, contacts name: Yong Zhang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.06488, lon: 120.38042, locations facility: Central Hospital Affiliated to Shangdong First Medical University, city: Jinan, state: Shangdong, country: China, contacts name: Liqun Jiao, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.66833, lon: 116.99722, locations facility: Lishui Central Hospital, city: Lishui, state: Zhejiang, country: China, contacts name: Xueli Cai, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.46042, lon: 119.91029, locations facility: Xuanwu Hospital, Capital Medical University, city: Beijing, country: China, contacts name: Bin Yang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False