Clinical Outcomes, Safety, and Cost-Effectiveness Analysis of Two Catheters (Xianrui Da and Medtronic) in Radiofrequency Ablation for Varicose Veins

NCT07046286 · tracked via the Priya Life Science China tracker

Sponsor

Chengdu University of Traditional Chinese Medicine

Phase

Not applicable

Started

2025-08-01

Last updated

2025-07-01

Condition(s) studied

Varicose Veins of Lower LimbVenous Insufficiency of LegVascular Disease，Peripheral

Investigational drug(s) / intervention(s)

Compare the two brands of radiofrequency ablation catheters for the treatment of lower limb varicose veins.

Compare the two brands of radiofrequency ablation catheters for the treatment of lower limb varicose veins.: 1. 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.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

80 Years

Healthy volunteers

Inclusion Criteria: 1. Age between 18 and 80 years old. 2. Clinically diagnosed with primary lower extremity varicose veins, with CEAP grade C2 - C5, and requiring treatment of the great saphenous vein segment. 3. Doppler ultrasound confirms that the reflux time of the saphenofemoral vein valve is \> 1.0 second. 4. Doppler ultrasound confirms that the diameter of the great saphenous vein in the supine position is \> 3mm and \< 12mm. 5. Only one limb of each patient is included in the study. 6. The patient signs the informed consent form and is willing to cooperate with the examinations and follow - ups specified in the protocol. Exclusion Criteria: 1. Thrombosis in the great saphenous vein, or combined with deep vein thrombosis, or a history of deep vein thrombosis or pulmonary embolism. 2. Recurrent varicose veins after previous treatment. 3. Severe tortuosity of the great saphenous vein, with the expectation that the catheter cannot pass through. 4. Severe lower extremity ischemia (CLI). 5. Known allergy to drugs or device materials involved in the study. 6. History of cardiac pacemaker or defibrillator implantation. 7. Pregnant or breastfeeding women. 8. Currently participating in other drug or device studies. 9. Deemed unsuitable for endovenous treatment by the researcher.

Primary outcome measure(s)

Venous Closure Rate at 12 Months Post-operation — 12 months
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 (%)

Trial sites (1)

Facility	City	Region	Status
Hospital of Chengdu University of Traditional Chinese Medicine	Chengdu	Sichuan

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07046286 on ClinicalTrials.gov ↗ ← All trials in China