Study on Treatment of Varicose Veins by Endovenous Laser (1940 nm vs 1470 nm)

Official title

Randomized Comparative Study With Two Wavelengths 1470 nm and 1940 nm for the Treatment of Varicose Veins of the Lower Limbs by Endovenous Laser.

Overview

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

• Procedure EVLA 1940 nm
  Treatment of varicose veins by endothermic ablation with an endovenous laser at 1940 nm
• Procedure EVLA 1470 nm
  Treatment of varicose veins by endothermic ablation with an endovenous laser at 1470 nm

Primary outcome measures

• Anatomical success [Time frame: At 5 years]

Secondary outcome measures (6)

• VAS Pain [Time frame: Day 0, Day 8, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5]
• Adverse Events [Time frame: Day 0, Day 8, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5]
• Venous Clinical Severity [Time frame: Day 0, Day 8, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5]
• Symptoms [Time frame: Day 0, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5]
• Patient quality of life (1) [Time frame: Day 0, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5]
• Patient quality of life (2) [Time frame: Day 0, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

France · 1 center

• Clinique Pasteur — Toulouse

Identifiers

NCT: NCT05663359 · 2022-A01722-41

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗