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
No
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
More Chengdu University of Traditional Chinese Medicine trials in China
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.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time on our Cookie Policy page. See also our Privacy Policy.