Prospective, multicenter, randomized, parallel-controlled, non-inferior clinical trial of the efficacy and safety of the Venous closure system for the treatment of varicose great saphenous veins

Authors
Category Primary study
Registry of TrialsChinese Clinical Trial Register
Year 2023
INTERVENTION: Experimental group:Venous closure system ;Control group:Intravascular radiofrequency closure system; CONDITION: Varicose great saphenous veins of lower extremities PRIMARY OUTCOME: Rate of main saphenous vein occlusion 3 months after surgery; SECONDARY OUTCOME: 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; 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.
Epistemonikos ID: 78f3209cf758e074fc8cbdb1558dbe3b9f57983d
First added on: Feb 20, 2024