Lower extremity varicose saphenous veins
Conditions
Interventions
Experimental group:Treated with endovenous radiofrequency ablation system produced by WE Medical Technology (Wuxi) Co., LTD
Control group:Treated with endovenous radiofrequency ablation system produced by Medtronic Inc.
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. No gender limitation, age 18-80 (including 18 and 80 years old); 2. Patients currently diagnosed with varicose great saphenous veins, the CEAP (Clinical, Etiologic, Anatomic, and Pathophysiologic) grading of varicose veins was C2-C6; 3. Varicose veins of the saphenous vein (superficial veins only) need treatment; 4. Be able to communicate smoothly, understand and be willing to complete the study in strict compliance with the requirements of this protocol; 5. Agree to participate in the clinical trial and sign the informed consent voluntarily.
Exclusion criteria
Exclusion criteria: 1. Patients with deep vein thrombosis (DVT) formation or high risk of DVT. 2. Some conditions affecting the saphenous vein cannot be treated using RFA ablation, including:- Secondary varicose veins;- Previous surgical treatment of the saphenous vein;- Saphenous vein thrombosis, thrombophlebitis;- Space between the intima of saphenous vein and skin 3 times the normal upper limit; creatinine > 225 µmol/L). 4. Coagulation dysfunction or significant bleeding tendency (platelets = 30×10^9/L). 5. Systemic acute infectious disease. 6. Contraindications to anaesthesia. 7. Women who are pregnant, breastfeeding, or unable to use effective contraception during the study period. 8. Participation in another clinical trial within three months. 9. Malignant tumours with survival of less than 1 year. 10. Other conditions that, in the opinion of the investigator, make participation in this trial inappropriate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of saphenous vein occlusion 6 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Venous clinical severity score;Aberdeen varicose vein questionnaire;Instrument performance evaluation; | — |
Countries
China
Contacts
Public ContactYinghua Zhou
Peking University First Hospital
Outcome results
None listed