Study on Treatment of Varicose Veins by Endovenous Laser (1940 nm vs 1470 nm)
ConditionVaricose Veins
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinique Pasteur
About this trial
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.
Eligibility criteria
Qualifiers
Primary insufficiency of the great saphenous vein (GSV) and/or small saphenous vein (SSV)
Patient candidate for endothermic treatment of the lower limbs
CEAP: C2 - C6
Patient with a target vein diameter (GSV and/or SSV) >= 3 mm throughout the target vein segment
Disqualifiers
Patient with a current serious pathology and/or a life expectancy of less than 5 years
Patient who has had a deep or superficial vein thrombosis in the previous 6 months
Obliterating arteriopathy of the lower limb concerned, with an IPS < 0.8 or > 1.3
Patient with post-thrombotic obstructive syndrome at the popliteal and/or femoral and/or iliac stage on the ipsilateral lower limb
Trial design
Treatments tested in this trial
- EVLA 1940 nm
- EVLA 1470 nm
Treatment groups
280 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov