Prospective Multicentric Randomised Trial Between Radiofrequency Ablation With VNUS Closure Fast ® and Endovenous Ablation With 1470 nm Diod Laser and Tulip Fiber ® for Treatment of Primary Venous Insufficiency.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 280
- 试验地点
- 6
- 主要终点
- Closure of the greater saphenous vein at 12 months.
研究概览
简要总结
Endovenous ablation of the greater saphenous vein has nowadays the same outcome as open crossectomy and stripping. The two most performed techniques for endovenous ablation are the endovenous laser ablation and the radiofrequency ablation. According to the trial of Rasmussen, they are equivalent for occlusion but the lower laser wave lengths resulted in more pain and paresthesia. The newer wave length of 1470 nm showed lesser side effects in observational studies. The aim of this study is to compare radiofrequency ablation with the VNUS closure fast ® with laser ablation with a 1470 nm wave length in combination with a new fiber, the Tulip fiber ®. This fiber has the shape of a tulip at his tip which avoids point necroses of the vessel wall and on consequence results in lesser side effects from wall perforations such as pain, haematoma,...
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Endovenous ablation of the great saphenous vein (GSV) planned
- •Patient signed informed consent
- •Patient must complete the 1 year follow-up
- •CEAP between 2 and 6
- •Diameter of the GSV in upward position less than 20 mm diameter
- •No problems in deep venous system
排除标准
- •No informed consent is signed
- •Latex allergy
- •Arterial insufficiency
- •Deep vein thrombosis or deep vein insufficiency
- •Klippel Trenaunay
- •Diameter fo GSV > 20 mm
- •Cross dilation with 2 or more insufficient side branches
- •Previous GSV operation
- •Redo-operation
- •Carcinoma less than 1 year ago
- •BMI > 35
- •Liver-insufficiency with contraindication for local tumescence
- •Intake of warfarins
- •Pregnancy, breastfeeding, < 3 months after pregnancy
- •Bilateral GSV insufficiency that has to be treated
- •Cross insufficiency of the accessory saphenous vein or insufficiency of the subterminal valve of the GSV
结局指标
主要结局
Closure of the greater saphenous vein at 12 months.
时间窗: 12 months after procedure
Closure of the greater saphenous vein will be measured by venous duplex, Kabnick score and modified Gelev score. This will be performed after 5 days, 1 month, 6 months and 12 months.
次要结局
- Pain.(after 1 year.)
- Incapacity to work.(After 1 year)
- Patient satisfaction rate.(After 1 year.)
- Pain satisfaction rate.(After 6 months)