Chronic venous insufficiency (CVI)
Conditions
Interventions
Anticoagulation group:apixaban
placebo group:placebo
Sponsors
The second affiliated hospital of Zhejiang University school of medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1.The diameter of the main trunk of the great saphenous vein ranges from 3 mm to 15 mm (measured 3 cm below the saphenofemoral junction); 2.Age =18 years and =80 years; 3.Patients meeting C2–C6 classification criteria according to the CEAP grading system established by the International Venous Society, with unilateral limbs included in the study; 4.Pathological venous reflux (reflux time> 0.5 s) in the great saphenous vein confirmed by lower extremity color Doppler ultrasound, with reflux involving the saphenofemoral junction or the main trunk in the femoral segment; 5.Meeting the investigator's criteria for suitability for radiofrequency ablation (RFA) treatment; 6.Ability to understand and sign an informed consent form, demonstrating good compliance;
Exclusion criteria
Exclusion criteria: 1. History of surgery on the same side veins, deep vein thrombosis in the lower limbs, and/or history of pulmonary embolism; 2. Congenital venous malformations (such as Klippel-Trenaunay syndrome, arteriovenous fistula, etc.); 3. Unable to walk or long-term immobilization, restricted bed rest; 4. Severe lower limb ischemia or confirmed severe peripheral arterial occlusive disease; 5. Severe renal insufficiency or allergy to drugs or medical devices involved in the study; 6. Using anticoagulants before surgery that cannot be stopped postoperatively (Warfarin, DOACs) or dual antiplatelet drugs; 7. Active bleeding disorders (such as peptic ulcers, recent cerebral hemorrhage), coagulation disorders (platelets 1.5); 8. High-risk patients according to Caprini score; 9. Blood hypercoagulable states (such as myeloproliferative diseases); 10. Paroxysmal nocturnal hemoglobinuria; 11. Sjögren's syndrome, SLE, or use of oral corticosteroids; 12. Antiphospholipid antibody syndrome; 13. Investigator expects life expectancy < 12 months; 14. Inferior vena cava and/or iliac vein stenosis or occlusion; 15. Known hereditary thrombophilia (such as antithrombin deficiency, protein C/S deficiency, etc.); 16. Other serious illnesses; 17. Pregnant, breastfeeding, or women planning pregnancy during the study; 18. Patients unable to cooperate with required examinations and follow-ups in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Composite endpoint of VTE and all-cause mortality; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of bleeding events;Anatomical closure rate of the great saphenous vein; | — |
Countries
China
Contacts
Public ContactZhenjie Liu
The second affiliated hospital of Zhejiang University school of medicine
Outcome results
None listed