Varicose great saphenous veins of lower extremities
Conditions
Interventions
Experimental group:Venous closure system
Control group:Intravascular radiofrequency closure system
Sponsors
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: (1) No gender limitation, age 18-75 (including 18 and 75 years old); (2) Patients currently diagnosed with varicose great saphenous veins; (3) The CEAP (Clinical, Etiologic, Anatomic, and Pathophysiologic) grading of varicose veins was C2-C5; (4) Agree to participate in the clinical trial and sign the informed consent voluntarily.
Exclusion criteria
Exclusion criteria: (1) Patients currently diagnosed with pulmonary embolism or lower limb venous thrombosis. (2) Patients currently diagnosed with malignant tumors. (3) Patients currently diagnosed with thrombophlebitis. (4) Patients with a history of lower extremity venous surgery in the affected limb to be treated. (5) Patients who are allergic to any component of the test device or control device. (6) Patients with a history of congenital hemorrhagic disease (e.g., hemophilia), or any current active clinically significant bleeding, or a current significant coagulation disorder (if one of the following criteria is met, the patient is considered to have a significant coagulation disorder: platelet count =50×109/L; Prothrombin time exceeded the normal reference range by 3s). (7) Patients determined by the researcher to have local acute infection at the intended puncture site. (8) Patients with one of the current conditions of bacteremia, sepsis or sepsis. (9) The diameter of the main saphenous vein to be treated was > 12mm. (10) Women who are currently pregnant or breastfeeding. (11) Patients who planned to have children during the trial. (12) Patients who participated in other interventional clinical trials within 30 days. (13) Patients with mental diseases, unable to cooperate with treatment or follow-up. (14) As assessed by the investigators, the proposed treatment site of the great saphenous vein was severely distorted, vascular malformation or phlebiomatous dilatation, which was not suitable for the patients enrolled in this clinical trial. (15) Any other conditions that the investigator deems unsuitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of main saphenous vein occlusion 3 months after surgery; | — |
Secondary
| Measure | Time frame |
|---|---|
| Instrument performance evaluation;Success rate of treatment of great saphenous vein occlusion;Great saphenous vein main treatment site pain score;VCSS scores improve the situation;Success rate of device;Ecchymosis score of main saphenous vein treatment site;Great saphenous vein occlusion rate 1 month after surgery;The great saphenous vein was occluded 6 months after surgery;The great saphenous vein was occluded 12 months after surgery; | — |
Countries
China
Contacts
Public ContactXinwu Lu
Department of Vascular Surgery, Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Outcome results
None listed