[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100596501":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":25,"centralContacts":26,"locations":32,"responsibleParty":48,"collaborators":25,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":25,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":25,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":73,"overallStatus":77,"whyStopped":25,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":87},{"fullName":5,"class":6},"Chengdu University of Traditional Chinese Medicine","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental Group: Treatment of great saphenous vein varicosity using the Xianruida AcoArt Venous™","EXPERIMENTAL","Experimental group: Xianruida Endovenous Radiofrequency Ablation Catheter Participants will receive endovenous radiofrequency ablation (RFA) using the Xianruida catheter. The procedure includes catheter insertion into the target vein under ultrasound guidance. Data on surgery date, limb position, treatment length, and device performance will be recorded.",[13],"Procedure: Compare the two brands of radiofrequency ablation catheters for the treatment of lower limb varicose veins.",{"label":15,"type":16,"description":17,"interventionNames":18},"Control Group: Treatment of great saphenous vein varicosity using the Medtronic ClosureFast™ endoven","ACTIVE_COMPARATOR","Control group: Medtronic ClosureFast™ Endovenous Radiofrequency Ablation Catheter Participants will undergo RFA using the Medtronic ClosureFast™ catheter. The procedure is similar to the experimental arm, with the same temperature and withdrawal speed settings. Data collected will include surgery date, limb position, treatment length, and device performance.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"PROCEDURE","Compare the two brands of radiofrequency ablation catheters for the treatment of lower limb varicose veins.","1. Surgical Procedures: Standardized radiofrequency ablation (GSV\u002FSSV closure) was carried out in both groups by the same team. Catheter parameters were set as 120°C and 1 cm\u002Fmin withdrawal speed. The treatment segment of the great saphenous vein was required to be \\>1 cm from the skin before anesthesia. For calf varicose veins, treatment was done after great saphenous vein ablation.\n\n   * Experimental Group: Utilized Xianruida's catheter with advanced features. Surgical and device - related information was recorded.\n   * Control Group: Used Medtronic's catheter. Similar data were recorded as in the experimental group.\n2. Postoperative Management: Consistent for both groups.\n\n   * Compression: Applied elastic bandage + Class II compression stockings.\n   * Medication: Patients took oral anticoagulants and painkillers as needed, with usage details recorded during follow - up.",[15,9],null,[27],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},"Chunshui He, Doctor","CONTACT","86-18981885601","Chunshuihe@msn.com",[33],{"facility":34,"status":25,"city":35,"state":36,"zip":37,"country":38,"countryCode":39,"cosmosGeoPoint":40,"geoPoint":45,"contacts":46},"Hospital of Chengdu University of Traditional Chinese Medicine","Chengdu","Sichuan","610000","China","CN",{"type":41,"coordinates":42},"Point",[43,44],104.06667,30.66667,{"lat":44,"lon":43},[47],{"name":28,"role":29,"phone":30,"phoneExt":25,"email":31},{"type":49,"investigatorFullName":50,"investigatorTitle":51,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"PRINCIPAL_INVESTIGATOR","Chunshui He","Director of Vascular Surgery in ChengduUTCM","100596501","clinical-outcomes-safety-and-cost-effectiveness-analysis-of-two-catheters-xianrui-da-and-medtronic-in-radiofrequency-ablation-for-varicose-veins-100596501",false,"NCT07046286","Clinical Outcomes, Safety, and Cost-Effectiveness Analysis of Two Catheters (Xianrui Da and Medtronic) in Radiofrequency Ablation for Varicose Veins","Clinical Outcomes, Safety, and Cost-Effectiveness Analysis of Two Catheters (Xianrui and Medtronic) in Radiofrequency Ablation for Varicose Veins","Inclusion Criteria:\n\n1. Age between 18 and 80 years old.\n2. Clinically diagnosed with primary lower extremity varicose veins, with CEAP grade C2 - C5, and requiring treatment of the great saphenous vein segment.\n3. Doppler ultrasound confirms that the reflux time of the saphenofemoral vein valve is \\> 1.0 second.\n4. Doppler ultrasound confirms that the diameter of the great saphenous vein in the supine position is \\> 3mm and \\\u003C 12mm.\n5. Only one limb of each patient is included in the study.\n6. The patient signs the informed consent form and is willing to cooperate with the examinations and follow - ups specified in the protocol.\n\nExclusion Criteria:\n\n1. Thrombosis in the great saphenous vein, or combined with deep vein thrombosis, or a history of deep vein thrombosis or pulmonary embolism.\n2. Recurrent varicose veins after previous treatment.\n3. Severe tortuosity of the great saphenous vein, with the expectation that the catheter cannot pass through.\n4. Severe lower extremity ischemia (CLI).\n5. Known allergy to drugs or device materials involved in the study.\n6. History of cardiac pacemaker or defibrillator implantation.\n7. Pregnant or breastfeeding women.\n8. Currently participating in other drug or device studies.\n9. Deemed unsuitable for endovenous treatment by the researcher.","ALL","18 Years","80 Years",{"count":63,"type":64},200,"ESTIMATED","INTERVENTIONAL",[67],"NA","This study aims to systematically compare the clinical efficacy (venous closure rate and symptom relief rate), safety (perioperative and postoperative complications), and cost-effectiveness (direct medical costs) of domestic Xianruida radiofrequency catheter and imported Medtronic catheter in endovenous radiofrequency ablation for varicose veins through a single-center, prospective, non-inferiority randomized controlled trial.",[70,71,72],"Varicose Veins of Lower Limb","Venous Insufficiency of Leg","Vascular Disease，Peripheral",[74,75,76],"varicose veins of the great saphenous veins","radiofrequency ablation","catheters","NOT_YET_RECRUITING","2025-06-29",{"date":80,"type":81},"2025-07-01","ACTUAL",{"date":83,"type":64},"2025-08-01",{"date":85,"type":64},"2026-10-01",{"name":5,"class":6},1]