Varicose veins of the lower extremities
Conditions
Interventions
Experimental group:Varicose closure glue
Controlled group:Radiofrequency ablation catheter
Sponsors
Zhejiang Provincial People‘s Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age 18 to 80 years, regardless of gender; 2. Doppler ultrasound confirmed that the valve regurgitation time of saphenofemoral vein was > 0.5 seconds; 3. Doppler ultrasound confirmed that the diameter of great saphenous vein was more than 3mm and less than 15mm; 4. The clinical diagnosis was varicose veins of lower extremities, the clinical symptom grade of CEAP was C2-C5, and the great saphenous vein segment needed to be treated; 5. Patients or their guardians can understand the purpose of the trial, voluntarily participate in and sign the written informed consent form, and can accept follow-up.
Exclusion criteria
Exclusion criteria: 1. The life expectancy is less than 1 year; 2. Great saphenous vein thrombosis; 3. Deep vein thrombosis, or previous history of deep vein thrombosis,pulmonary embolism; 4. Patients with varicose veins of lower extremities with previous surgical intervention; 5. Pregnant or lactating women, or those who plan to become pregnant within one year; 6. Those who are known to be allergic to the drugs, instruments and materials involved in the study; 7. Participate in clinical trials of other experimental biological agents or drugs or devices, and fail to reach the primary endpoint at the time of enrollment; 8. Other conditions in which the patient is not considered suitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of complete occlusion of treated segment vein; | — |
Secondary
| Measure | Time frame |
|---|---|
| Success rate of device;Success rate of operation;CEAP clinical symptom classification;Incidence rate of Device defect;Incidence rate of adverse event and Serious adverse event; | — |
Countries
China
Contacts
Public ContactJinsong Jiang
Zhejiang Provincial People‘s Hospital
Outcome results
None listed