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

Launched by CHENGDU UNIVERSITY OF TRADITIONAL CHINESE MEDICINE · Jun 29, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at two different types of catheters used to treat varicose veins in the legs with a procedure called radiofrequency ablation. This treatment uses heat to close off faulty veins, helping to reduce symptoms like pain and swelling. The study compares a domestic catheter called Xianrui Da with an imported one made by Medtronic to see which one works better, is safer, and costs less.

Adults between 18 and 80 years old with diagnosed varicose veins in one leg may be eligible if their vein problems meet certain ultrasound criteria. Participants will receive treatment with one of the two catheters and will be closely monitored to check how well the veins close, how symptoms improve, and if there are any side effects or complications. The study also looks at the overall cost of each treatment. People with serious vein clots, previous vein treatments, or certain health conditions won’t be able to join. If you have varicose veins and want to learn about new treatment options, this study might be of interest once it starts recruiting.

Gender

ALL

Eligibility criteria

• 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.