NL-OMON26692暂停不适用

Mechanochemical Endovenous ablation (MOCATM) versus radiofrequency ablation (RFA) in the treatment of primary Small Saphenous vein Insufficiency: a multicentre randomized trial.<br><br>Mechanochemische endoveneuze ablatie versus radiofrequente ablatie in de behandeling van primaire insufficientie van de vena saphena parva: een multi-centrum gerandomiseerde studie

St. Antonius Ziekenhuis Nieuwegein afd HeelkundeRijnstate Ziekenhuis Arnhem afd Heelkunde0 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

适应症

试验速览

Elias S, Raines JK.Mechanochemical tumescentless endovenous ablation: final results of the initial clinical trial. Phlebology. 2012;27:67-72.
2. Van Eekeren RRJP, Boersma D, Elias S, Holewijn S, Werson DAB, De Vries JPPM, Reijnen MMJP. Mechanochemical endovenous ablation of great saphenous vein incompetence using the ClariVein® device: a safety study. J Endovasc Ther. 2011;18:328-334
3. Boersma D, Van Eekeren RRJP, Werson DAB, De Vries JPPM, Reijnen MMJP. Mechanochemical endovenous ablation of small saphenous vein insufficiency using the ClariVein® device: One-year results of a prospective series. EJVES 2013;45(3): 299-303
4. Bishawi M, Bernstein R, Boter M, Draugh D, Gould C, Hamilton C, Koziarski J. Mechanochemical ablation in patients with chronic venous disease: a prospective multicenter report. Phlebology. 2013; Epub ahead of print

•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.

发起方

St. Antonius Ziekenhuis Nieuwegein afd HeelkundeRijnstate Ziekenhuis Arnhem afd Heelkunde