Vacuum-assisted Laser Ablation (VALA) for Treatment of Large Saphenous Veins

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorCenter Of Phlebology

About this trial

Endovenous thermal ablation (EVTA), including radiofrequency ablation (RFA) and endovenous laser ablation (EVLA), is considered the main method for the treatment of symptomatic truncal vein reflux. However, there are controversial data concerning their efficacy and safety in ablating large saphenous veins because of high risk of heat-induced thrombosis (EHIT), incomplete ablation and recanalization.1-5 The use of vacuum evacuation of the remaining intraluminal blood during endovenous laser ablation allows to decrease the risk of intraoperative (carbonization and destruction of the fiber lens) and postoperative complications (EHIT, hyperpigmentation, "string" feeling) and leads to reduction of recovery because of short period of vein resorption. The aim of the study is to evaluate the safety and effectiveness of endovenous thermal ablation with or without vacuum evacuation for the treatment of incompetent large saphenous veins (\>15 mm).

Eligibility criteria

Qualifiers

Age over 18 years

Varicose veins of the lower extremities with clinical class C2-C6 with a diameter of the GSV or SSV ≥ 15 mm in a standing position

Informed consent

Disqualifiers

pregnancy or lactation

malignant neoplasms

inability or unwillingness of any patient to wear compression stockings

hypersensitivity to lidocaine

Trial design

Treatments tested in this trial

  • Procedure: EVLA
  • Procedure: VALA

Treatment groups

184 Participants
are divided into 2 treatment groups

Sponsors and collaborators