Varicose great saphenous veins of lower extremities (limited to superficial veins)
Conditions
Interventions
Experimental group :Treated with varicose vein closure system produced by Shanghai Yimiao Medical equipment Co., Ltd.
Sponsors
Shanghai Changzheng Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years, no gender limit; 2. Clinical diagnosis of unilateral / bilateral varicose great saphenous veins of lower extremities (superficial veins only). This operation only deals with patients with unilateral trunk of great saphenous veins; 3. Patients with CEAP grade C2-C4b; 4. Voluntarily participate in this study, understand all the risks and benefits described in the informed consent document and sign a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Daily use of anesthesia or non-steroidal anti-inflammatory painkillers to control pain associated with varicose veins; 2. Severe hepatic and renal dysfunction (ALT> 3 times the upper limit of normal; Creatinine >221umol/L); 3. Patients with known uncorrected bleeding or severe clotting diseases; 4. Patients with vessel diameter 12mm in the target segment of the great saphenous vein; 5. Patients with symptomatic peripheral artery disease; 6. Patients with target venous tumor with local diameter >12 mm; 7. Patients with acute systemic infectious diseases; 8. Patients with superficial thrombophlebitis; 9. Patients who have received interventional or surgical treatment for the main saphenous vein of the target limb; 10. Patients with other diseases that may make the test difficult or significantly shorten the patient's life expectancy (<1 year), such as tumors, liver disease, cardiac insufficiency, etc.; 11. Patients with known allergy to local anesthetic agents such as lidocaine or cyanoacrylates; 12. Patients with non-primary varicose veins, including but not limited to pelvic tumor, deep vein thrombosis sequela, KT syndrome or arteriovenous fistula history; 13. Patients with extreme distortion of the great saphenous vein are not suitable for minimally invasive interventional treatment; 14. Pregnant and lactating patients; 15. Patients who are participating in clinical trials of other drugs or medical devices; 16. Patients considered unsuitable for inclusion for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Complete closure rate of great saphenous vein 3 months after operation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate of operation;Pain score;Performance evaluation of varicose vein sealing system;Ecchymosis evaluation at 7 days (± 3 days) after surgery;Venous clinical severity score (VCSS) before and after surgery;Aberdeen varicose vein questionnaire (AVVQ) before and after surgery;Operation time; | — |
Countries
China
Contacts
Public ContactQu Lefeng
Shanghai Changzheng Hospital
Outcome results
None listed