Varicose vein of lower limb
Conditions
Interventions
Experimental group:Vein closure system
Control group:Intravenous radiofrequency closure generator
Sponsors
Shanghai Ninth People's hospital,shanghai jiaotong University School of medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age>=18 years old and <=80 years old, gender is not limited; 2. Clinical diagnosis of unilateral or bilateral saphenous varicose veins of the lower extremities (primary). This surgery only treats unilateral saphenous varicose veins of the lower extremity (primary), and for bilateral saphenous varicose veins of the lower extremities (primary), this surgery only treats one side (investigator's judgment); 3. Patients with CEAP grade C2-C4b; 4. Understand the purpose and process of the trial, voluntarily participate, and can sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Patients who had previously received surgical treatment for the target vascular lesion; 2. Acute thrombosis in the main trunk of great saphenous vein; 3. Patients with acute superficial thrombophlebitis; 4. Patients with migratory thrombophlebitis; 5. Patients with target lesion venous vessel diameter 15mm; 6. Patients with tuberoid dilatation at the cryptic femoral junction; 7. Patients with extreme distortion of the great saphenous vein are not suitable for radiofrequency ablation; 8. Patients with deep vein thrombosis; 9. Patients with active implants such as pacemakers in their bodies; 10. Patients with severe liver and kidney dysfunction (ALT or AST> 3 times the upper limit of normal; Scr>225µmol/L); 11. Patients with acute and chronic arterial ischemic clinical manifestations (lower limbs); 12. Patients who are known to be allergic to local anesthetic drugs such as lidocaine and cyanoacrylate; 13. Post-deep vein thrombosis syndrome, KT syndrome (venous malformation bone hypertrophy syndrome), Patients with non-primary varicose veins caused by arteriovenous fistula; 14. The disease may be difficult to treat and evaluate (e.g., malignancy, acute infection) Disease, sepsis, systemic inability to tolerate surgery, inability to walk independently, low life expectancyIn 12 months, etc.) patients; 15. Pregnant and lactating women, or those who planned to give birth during the study period; 16.Patients who have participated in clinical trials of other drugs or medical devices within the last 3 months; 17. The investigator considered other patients unfit to participate in this study.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Technical success rate (the instrument is delivered in place and retracted smoothly, and the target vein and blood vessels are checked by ultrasound immediately for no blood flow);Changes in venous clinical severity (VCSS) scores ;Changes in the score of the varicose vein questionnaire (AVVQ); | — |
Primary
| Measure | Time frame |
|---|---|
| Complete closure rate of target vein 180 days after surgery; | — |
Countries
China
Contacts
Public ContactXinwu Lu
Shanghai Ninth People's hospital,shanghai jiaotong University School of medicine
Outcome results
None listed