ACOART RF CLOSURE:Radiofrequency for Varicose Veins of Lower Extremity in China

This trial is a prospective, multi-center, 1:1 randomized using endovenous radiofrequency closure catheter and endovenous radiofrequency closure generator versus ClosureFast™ and ClosureRFG™ to treat varicose veins of lower extremity. And parimary endpoint is Complete closure rate of great saphenous vein at 6 months post-procedure.

Inclusion criteria

• 18 to 80 years of age
• Patients clinically diagnosed as primary varicose great saphenous veins of lower extremity. And unilateral superficial varicose veins of lower extremity will be treated in this procedure.
• Patients with CEAP classification as C2-C5.
• Voluntarily participate in this study and sign the informed consent form

Exclusion criteria

• patients with target vein diameter < 2mm or > 15mm.
• the distance between the anterior wall of the vessel and the skin of the target vein under ultrasound is less than 0.5cm.
• patients with aneurysmal dilation at the saphenous femoral junction.
• patients with venous aneurysm (defined as venous hemangioma with a diameter greater than or equal to 2 times the diameter of the adjacent vein).
• thrombosis or thrombophlebitis in the trunk of great saphenous vein.
• the great saphenous vein is so tortuous that radiofrequency closure catheter cannot cross the vein trunk.
• patients with target diseased vessels who have received surgical treatment in the past.
• patients with deep venous thrombosis or a history of pulmonary embolism.
• patients with active implants such as pacemakers or ICD.
• patients with severe hepatic and renal dysfunction (ALT > normal upper limit 3 times; creatinine > 225umol/L).
• patients who are contraindications to anesthesia.
• patients with secondary varicose veins caused by deep venous thrombosis syndrome, Cockett syndrome (iliac vein compression syndrome), KT syndrome (venous malformation hypertrophy syndrome), arteriovenous fistula, etc.
• any serious or uncontrollable systemic disease (including uncontrolled hypertension, diabetes, active bleeding signs or severe coagulation disorders, etc.).
• patients with diseases that may cause difficulties in treatment and evaluation (such as malignant tumors, acute infectious diseases, septicemia, general intolerability of surgery, life expectancy less than 12 months, etc.).
• pregnant and lactating women, or those who had a planned birth during the study period.
• patients who have participated in clinical trials of other drugs or medical devices in the past 3 months.
• According to the judgement of the investigator, other situations that are not suitable for enrollment.