Mechanochemical Endovenous ablation (MOCATM) versus radiofrequency ablation (RFA) in the treatment of primary Small Saphenous vein Insufficiency: a multicentre randomized trial - MESSI-trial

Sint Antonius Ziekenhuis0 个研究点目标入组 160 人开始时间: 待定最近更新: 2024年6月11日

试验速览

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•1. Primary SSV incompetence
•2. Symptomatic varicose veins, C1-C5
•3. Duplex ultrasound criteria meet criteria for general endovenous treatment: diameter of small saphenous vein > 3 mm and < 12 mm, non-tortuous
•4. Signed informed consent
•5. Patient is willing to participate in follow up
•6. Age> 18 year and < 80 year

•1. Patient is incapable of informed consent
•2. Pregnancy and lactation
•3. C6 varicose veins
•4. Pervious surgical or endovenous treatment of the affected vein
•5. History of deep venous thrombosis in the affected leg
•6. Oral anticoagulants
•7. Contraindication or known allergy to sclerosans
•8. Immobilization
•9. Coagulation disorders or increased risk of thrombo-embolic complications: known coagulation disorders as hemophilia A, hemophilia B, Von Willebrandt disease, Glanzmann disease, factor VII-deficiency, idiopathic trombocytopenic purpura, factor V Leiden, deep venous thrombosis or pulmonary embolism in medical history
•10. Fontaine III of IV peripheral arterial disease
•11. Severe renal insufficiency: known glomerular filtration rate < 30 mL/min
•12. Liver disease, associated with changes in coagulation, anemnestic evidence of bleeding as epistaxis and spontaneous hematoma, liver cirrhosis.

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