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

Launched by CLINIQUE PASTEUR · Dec 15, 2022

Keywords

ClinConnect Summary

This clinical trial is studying two different wavelengths of laser treatment for varicose veins in the legs. Specifically, it aims to find out if using a laser with a higher wavelength (1940 nm) is more effective and results in less pain or fewer complications compared to a lower wavelength (1470 nm). Patients who have been diagnosed with varicose veins and are eligible for this treatment may participate in the trial. To join, they need to have specific conditions related to their veins and be able to provide informed consent.

Participants in this study will receive one of the two laser treatments and will be followed for five years to monitor their recovery, any complications, and their overall quality of life. This long-term follow-up will help researchers understand which treatment works better and is safer for patients. It's important to note that certain individuals, such as those with serious health issues or specific vein problems, may not be eligible to participate in the trial.

Gender

ALL

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.