Varicose veins of the lower extremities, as a form of chronic venous disease (CVD), is one of the most common diseases of the venous system, with only cosmetic changes in the early stages, but with the aggravation of the varicose veins, there are complications such as swelling of the lower extremities, hyperpigmentation, itching of the skin, difficulty in walking, liposclerosis, and even hemorrhag
Conditions
Interventions
Venous RF Radiofrequency Ablation System Treatment Group:Ultrasound guided Venous RF radiofrequency ablation system for the treatment of lower limb varicose veins
Sponsors
Zhongshan Hospital, Fudan University
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. A clear diagnosis of primary lower extremity varicose veins by clinical examination; 2. CEAP grading of C2-C6; 3. Target veins 2 mm = diameter = 15 mm and deep vein patency; 4. Expected survival = 1 year; 5. can tolerate surgery; 6. no serious psychiatric diseases as well as organic diseases; 7. no history of allergy to sclerosing agent and anesthesia.
Exclusion criteria
Exclusion criteria: 1. Patients with combined lower extremity DVT (deep vein thrombosis); 2. patients with acute thrombosis within the main trunk of the saphenous vein; 3. patients with iliac vein compression syndrome; 4. patients with verrucous dilatation of the femoral saphenous junction; 5. patients with a previous history of lower extremity varicose vein surgery; 6. severe tortuosity of the saphenous vein that prevents passage of the radiofrequency catheter; 7. uncorrected coagulopathy; 8. patients with severe hepatic and renal dysfunction; 9. patients on bed rest; 10. patients who are pregnant or breastfeeding, or who are scheduled to give birth during the study; 11. Participating in other device or drug clinical trials; 12. are, in the judgment of the investigator, unsuitable for participation in the clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Saphenous vein trunk closure rate at 2 years postoperatively; | — |
Secondary
| Measure | Time frame |
|---|---|
| Instant technical success rate;Venous Clinical Severity Score (VCSS) before and after surgery;Aberdeen Varicose Vein Questionnaire (AVVQ) before and after surgery;Complication rate;Performance Evaluation of Venous Ablation Generator and Venous Ablation Catheter; | — |
Countries
China
Contacts
Public ContactWeiguo Fu
Zhongshan Hospital, Fudan University
Outcome results
None listed