Varicose Veins
Conditions
Keywords
Endovenous laser ablation (EVLA)
Brief summary
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.
Interventions
PROCEDUREEVLA 1940 nm
Treatment of varicose veins by endothermic ablation with an endovenous laser at 1940 nm
PROCEDUREEVLA 1470 nm
Treatment of varicose veins by endothermic ablation with an endovenous laser at 1470 nm
Sponsors
Clinique Pasteur
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Patient affiliated or beneficiary of a social security scheme * Patient having signed the informed consent
Exclusion criteria
* 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 * Patient with primary or post-thrombotic axial deep venous reflux on the ipsilateral lower limb * Suspicion of non-post-thrombotic iliac compression on echo-doppler * Contraindication to the planned treatment technique * Patient whose geographical distance is not compatible with the follow-up of the study * Pregnant or breastfeeding women * Patient linguistically or psychologically unable to understand the information given, to give informed consent or to answer the study questionnaires. * Protected patients: Adults under guardianship, or other legal protection; Hospitalized without consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anatomical success | At 5 years | Closure of the target vein |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| VAS Pain | Day 0, Day 8, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5 | Visual Analogue Scale (0-100 mm); higher is worse |
| Adverse Events | Day 0, Day 8, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5 | Adverse events related to endovenous treatment |
| Venous Clinical Severity | Day 0, Day 8, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5 | Venous Clinical Severity Score (VCSS) ; score between 0 to 30; higher is worse |
| Symptoms | Day 0, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5 | VEINES Sym (VEnous INsufficiency Epidemiologic and Economic Study - Symptoms) questionnaire |
| Patient quality of life (1) | Day 0, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5 | VEINES Sym (VEnous INsufficiency Epidemiologic and Economic Study - quality of life ) questionnaire |
| Patient quality of life (2) | Day 0, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5 | EuroQol-5 Dimension (EQ5D) Quality of life survey |
Countries
France
Contacts
CONTACTNicolas NEAUME, MD
PRINCIPAL_INVESTIGATORNicolas NEAUME, MD
Clinique Pasteur
Outcome results
None listed