Randomized Comparative Study With Two Wavelengths 1470 nm and 1940 nm for the Treatment of Varicose Veins of the Lower Limbs by Endovenous Laser.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Anatomical success
研究概览
简要总结
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 :
- Is the increase of wavelength form 1470 nm to 1940 nm affect the efficacy of varicose veins treatment ?
- 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
1470 nm
Endovenous laser at 1470 nm
干预措施: EVLA 1470 nm (Procedure)
1940 nm
Endovenous laser at 1940 nm
干预措施: EVLA 1940 nm (Procedure)
结局指标
主要结局
Anatomical success
时间窗: At 5 years
Closure of the target vein
次要结局
- Adverse Events(Day 0, Day 8, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5)
- Venous Clinical Severity(Day 0, Day 8, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5)
- Symptoms(Day 0, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5)
- VAS Pain(Day 0, Day 8, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5)
- Patient quality of life (2)(Day 0, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5)
- Patient quality of life (1)(Day 0, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5)
研究者
Nicolas NEAUME
Principal Investigator, MD
Clinique Pasteur