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.
Age between 18 and 80 years old.
Clinically diagnosed with primary lower extremity varicose veins, with CEAP grade C2 - C5, and requiring treatment of the great saphenous vein segment.
Doppler ultrasound confirms that the reflux time of the saphenofemoral vein valve is > 1.0 second.
Doppler ultrasound confirms that the diameter of the great saphenous vein in the supine position is > 3mm and < 12mm.
Thrombosis in the great saphenous vein, or combined with deep vein thrombosis, or a history of deep vein thrombosis or pulmonary embolism.
Recurrent varicose veins after previous treatment.
Severe tortuosity of the great saphenous vein, with the expectation that the catheter cannot pass through.
Severe lower extremity ischemia (CLI).
Parallel
Compare the two brands of radiofrequency ablation catheters for the treatment of lower limb varicose veins.
Procedure/Surgery1. Surgical Procedures: Standardized radiofrequency ablation (GSV/SSV closure) was carried out in both groups by the same team. Catheter parameters were set as 120°C and 1 cm/min 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. * Experimental Group: Utilized Xianruida's catheter with advanced features. Surgical and device - related information was recorded. * Control Group: Used Medtronic's catheter. Similar data were recorded as in the experimental group. 2. Postoperative Management: Consistent for both groups. * Compression: Applied elastic bandage + Class II compression stockings. * Medication: Patients took oral anticoagulants and painkillers as needed, with usage details recorded during follow - up.
Venous Closure Rate at 12 Months Post-operation
The venous closure rate confirmed by ultrasound 12 months after surgery, categorized as complete closure (no blood flow signal) or partial closure (blood flow signal \< 10 cm).This classification is used to determine the difference in the effect of achieving venous occlusion between the two catheters. Unit of Measure: Percentage of closed veins (%)
Change in Aberdeen Varicose Vein Questionnaire (AVVQ) Score from
Change in AVVQ score (range 0-100) at 3, 6, and 12 months to assess patient-reported symptoms.Unit of Measure: Points on scale
Change in Venous Clinical Severity Score (VCSS) from Baseline
Change in VCSS score (range 0-30) at 3, 6, and 12 months after surgery to assess symptom improvement.Unit of Measure: Points on scale
Change in CIVIQ-20 Score from Baseline
Change in CIVIQ-20 score (range 0-100) at 3, 6, and 12 months to assess quality of life.Unit of Measure: Points on scale
Number of Intraoperative Complications
Number of events during surgery, such as perforation or catheter failure.Unit of Measure: Number of events
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