Vacuum-assisted Laser Ablation (VALA) for Treatment of Large Saphenous Veins
Endovenous Vacuum-assisted Laser Ablation (VALA) in the Treatment of Large Saphenous Veins (> 15 mm)
Center Of Phlebology
184 participants
Mar 15, 2025
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria3
- 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
Exclusion Criteria11
- pregnancy or lactation
- malignant neoplasms
- inability or unwillingness of any patient to wear compression stockings
- hypersensitivity to lidocaine
- concomitant diseases: diabetes mellitus, bronchial asthma, severe liver and kidney diseases, acute thrombosis and thrombophlebitis, skin and/or soft tissue infection, infectious diseases, obliterating peripheral arteriosclerosis, diabetic angiopathy, heart defects requiring surgical intervention, fever, toxic hyperthyroidism, obesity, tuberculosis, sepsis, blood cell composition disorder, all diseases requiring bed rest, heart disease with decompensation, known hereditary thrombophilia
- period after treatment for alcohol addiction
- sedentary lifestyle
- history of acute deep vein thrombosis
- history of superficial thrombophlebitis
- history of drug or other addiction
- use of oral contraceptives or other hormonal drugs
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Interventions
Great or small saphenous vein occlusion with endovenous laser ablation using ELVeS Radial 2ring fiber
Great or small saphenous vein occlusion with endovenous laser ablation using ELVeS Radial 2ring Pro fiber
Locations(9)
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NCT06971068