MOCA Versus RFA in the Treatment of Primary Great Saphenous Varicose Veins

Mechanochemical Endovenous Ablation (MOCA) Versus RADiofrequeNcy Ablation (RFA) in the Treatment of Primary Great Saphenous Varicose Veins: a Multicentre Randomized Trial

The newly developed Mechanochemical Endovenous Ablation (MOCA) device uses a technique that combines mechanical endothelial damage using a rotating wire with the infusion of a liquid sclerosant. Heating of the vein and tumescent anesthesia are not required; only local anesthesia is utilized at the insertion site. Previously we showed that endovenous MOCA, using polidocanol, is feasible and safe in the treatment of great spahenous vein (GSV) incompetence. However, larger studies with a prolonged follow-up to prove the efficacy of this technique in terms of obliteration rates are lacking. This randomized trial was designed to compare occlusion rate, post-operative pain and complications between radiofrequency ablation (RFA: the current treatment for GSV incompetence) en MOCA.

Inclusion Criteria:

• Insufficiency of the GSV
• Signed informed consent
• Patient willing to participate in follow-up scheme
• Age > 18 years
• Ultrasound criteria for endovenous treatment have been met:
• Diameter GSV between 3-12 mm
• No thrombus in the to be treated segment of the GSV

Exclusion Criteria:

• Patient not able to give informed consent
• Patient unable to present at follow-up visits
• Other treatment is more suitable
• Pregnancy and breast feeding
• Known allergy/ contra-indication for sclerotherapy
• Previous ipsilateral surgical treatment of varicose veins
• Deep venous thrombosis or lung emboli in medical history
• Anticoagulant therapy
• C5-C6 varices
• Immobilization
• Fontaine II or IV peripheral arterial disease
• Severe kidney function decline (GFS < 30 mL/min)
• Coagulation disorder or increased risk for thrombo-embolic complications(hemofilie A or B, v. Willebrand disease, Glanzmann disease, Factor VII-deficiency, idiopatic thrombocytopenic purpura, Factor V Leiden)
• Liver diseases accompanied by changes in blood coagulation, livver cirrhosis