Een multicenter, open-label, non-inferioriteit, gerandomiseerde, gecontroleerde studie waarin mechanochemische endoveneuze ablatie met behulp van Flebogrif wordt vergeleken met endoveneuze laserablatie voor de behandeling van primaire vena saphena magna insufficientie

Endovenous laser ablation (EVLA) is associated with an excellent outcome in the treatment of great saphenous vein incompetence (GSV). However, the use of thermal ablation requires tumescence anesthesia and is associated with risk of thermal damage. Mechanochemical endovenous ablation (MOCA) is a non-thermal ablation alternative which combines mechanical endothelial damage with the infusion of sclerosant foam injection. Tumescence anesthesia is not required. Preliminary experiences with MOCA using the Clarivein device showed less intraprocedural and postprocedural pain and a faster clinical improvement. Flebogrif is a relatively new MOCA device. To determine the role of MOCA using Flebogrif in the treatment of primary great saphenous vein incompetence, a well-designed randomized controlled clinical trial of sufficient sample size is required.

MOCA using Flebogrif is not inferior to EVLA for the treatment of GSV insufficiency.

Multicenter, open-label, non-inferiority, randomized controlled trial

Flebogrif vs EVLA