Beoordeling van mechanochemische endoveneuze behandeling in vergelijking met radiofrequente behandeling van spataderlijden ten gevolge van insufficientie van de vena saphena parva. Onderzoek in meerdere ziekenhuizen en in opzet van gerandomiseerde studie.

Suspended

Conditions: Symptomatic venous insufficiency of the small saphenous vein. Comparison of two endovenous treatment modalities.Spataderlijden ten gevolge van insufficientie van de vena saphena parva. Beoordeling van tweetal endoveneuze behandelingen.Keywords:small saphenous vein (SSV)varicose veinspolidocanolclariveinTrefwoordenvena saphena parva (VSP)spataderenpolidocanolclarivein

Registration Number: NL-OMON26692

Lead Sponsor: St. Antonius Ziekenhuis Nieuwegein afd HeelkundeRijnstate Ziekenhuis Arnhem afd Heelkunde

Brief Summary: 1. Elias S, Raines JK.Mechanochemical tumescentless endovenous ablation: final results of the initial clinical trial. Phlebology. 2012;27:67-72. <br> 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<br> 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<br> 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

Detailed Description: Not available

Recruitment & Eligibility

Status: Suspended

Sex: Not specified

Target Recruitment: 160

Inclusion Criteria

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

Exclusion Criteria

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.