The goal of this clinical trial is to compare efficacy of two wavelength for EndoVenous Laser Ablation (EVLA) in treatment of varicose veins of the lower limbs. The main questions it aims to answers are : 1. Is the increase of wavelength form 1470 nm to 1940 nm affect the efficacy of varicose veins treatment ? 2. Is the increase of wavelength reduce complication or pain ? Participants are patients with varicose veins of lower limbs and candidate for endovenous laser ablation. After laser ablation patients will be followed during 5 years for clinical evaluation, recording potential treatment complications and quality of life evaluation. Researchers will compare strategy 1(EVLA with an endovenous laser at 1940 nm) vs strategy 2 (EVLA with an endovenous laser at 1470 nm) in varicose veins treatment to see if efficacy of treatment is not reduce, and to see if complications of EVLA treatment can be reduced.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
280
Treatment of varicose veins by endothermic ablation with an endovenous laser at 1940 nm
Treatment of varicose veins by endothermic ablation with an endovenous laser at 1470 nm
Clinique Pasteur
Toulouse, France
RECRUITINGAnatomical success
Closure of the target vein
Time frame: At 5 years
VAS Pain
Visual Analogue Scale (0-100 mm); higher is worse
Time frame: Day 0, Day 8, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Adverse Events
Adverse events related to endovenous treatment
Time frame: Day 0, Day 8, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Venous Clinical Severity
Venous Clinical Severity Score (VCSS) ; score between 0 to 30; higher is worse
Time frame: Day 0, Day 8, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Symptoms
VEINES Sym (VEnous INsufficiency Epidemiologic and Economic Study - Symptoms) questionnaire
Time frame: Day 0, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Patient quality of life (1)
VEINES Sym (VEnous INsufficiency Epidemiologic and Economic Study - quality of life ) questionnaire
Time frame: Day 0, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Patient quality of life (2)
EuroQol-5 Dimension (EQ5D) Quality of life survey
Time frame: Day 0, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
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