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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Anatomical success [Срок оценки: At 5 years]

Вторичные конечные точки (6)

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

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 1 центр

• Clinique Pasteur — Toulouse

Идентификаторы

NCT: NCT05663359 · 2022-A01722-41

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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