varicosity
Conditions
Interventions
Experimental group:Trial group: Venous closure System (Shanghai Changde Medical Technology Co., LTD.)
Control group:Intra-venous radiofrequency closure catheter (Medtronic Inc.)
Sponsors
Zhejiang Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Age from 18 to 80 years old, regardless of gender; 2. The regurgitation time of saphenous femoral valve was > 0.5 seconds confirmed by Doppler ultrasound; 3. The diameter of saphenous vein was > 3mm and < 15mm by Doppler ultrasound; 4. The patient was clinically diagnosed as varicose veins of the lower extremity, and the CEAP clinical symptoms were classified as C2-C5, and the great saphenous vein segment needed treatment; 5.Patients or their guardians understood the purpose of the trial, volunteered to participate, provided written informed consent, and were available for follow-up.
Exclusion criteria
Exclusion criteria: 1. Life expectancy less than 1 year; 2. Great saphenous vein thrombosis; 3. Deep vein thrombosis, or previous history of deep vein thrombosis or pulmonary embolism; (4) patients with lower extremity varicose veins with previous surgical intervention of target lesions; 5. Pregnant or lactating women, or those planning to become pregnant within one year; 6. Those who are known to be allergic to the drugs or device materials involved in the study; 7. Participate in other investigational biologics or drug or device clinical trials and have not met the primary endpoint at enrollment;8. Patients were deemed by the investigator to be ineligible for other conditions.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of complete venous occlusion in the treatment segment 3 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Instrument success rate;Immediate technical success rate after surgery;achievement ratio of operation;VAS visual analogue score before discharge / 3 days after operation;Skin ecchymosis score of treated segment vein area before discharge / 3 days after operation;Clinical symptom classification of CEAP 3 months and 6 months after surgery;VCSS score 3 months and 6 months after surgery;AVVQ score 3 and 6 months after surgery;The rate of complete venous occlusion at 6 months and 12 months after operation;The incidence of device defects;Incidence of adverse events, serious adverse events; | — |
Countries
China
Contacts
Public ContactJiang Jinsong
Zhejiang Provincial People's Hospital
Outcome results
None listed