Mechanochemical Endovenous Ablation (MOCA) Versus RADiofrequeNcy Ablation (RFA) in the Treatment of Primary Great Saphenous Varicose Veins: a Multicentre Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 213
- 试验地点
- 5
- 主要终点
- Occlusion rate
研究概览
简要总结
The newly developed Mechanochemical Endovenous Ablation (MOCA) device uses a technique that combines mechanical endothelial damage using a rotating wire with the infusion of a liquid sclerosant. Heating of the vein and tumescent anesthesia are not required; only local anesthesia is utilized at the insertion site. Previously we showed that endovenous MOCA, using polidocanol, is feasible and safe in the treatment of great spahenous vein (GSV) incompetence. However, larger studies with a prolonged follow-up to prove the efficacy of this technique in terms of obliteration rates are lacking. This randomized trial was designed to compare occlusion rate, post-operative pain and complications between radiofrequency ablation (RFA: the current treatment for GSV incompetence) en MOCA.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Insufficiency of the GSV
- •Signed informed consent
- •Patient willing to participate in follow-up scheme
- •Age > 18 years
- •Ultrasound criteria for endovenous treatment have been met:
- •Diameter GSV between 3-12 mm
- •No thrombus in the to be treated segment of the GSV
排除标准
- •Patient not able to give informed consent
- •Patient unable to present at follow-up visits
- •Other treatment is more suitable
- •Pregnancy and breast feeding
- •Known allergy/ contra-indication for sclerotherapy
- •Previous ipsilateral surgical treatment of varicose veins
- •Deep venous thrombosis or lung emboli in medical history
- •Anticoagulant therapy
- •C5-C6 varices
- •Immobilization
- •Fontaine II or IV peripheral arterial disease
- •Severe kidney function decline (GFS < 30 mL/min)
- •Coagulation disorder or increased risk for thrombo-embolic complications(hemofilie A or B, v. Willebrand disease, Glanzmann disease, Factor VII-deficiency, idiopatic thrombocytopenic purpura, Factor V Leiden)
- •Liver diseases accompanied by changes in blood coagulation, livver cirrhosis
结局指标
主要结局
Occlusion rate
时间窗: up to 5 years
Occlusion rates between treatments will be compared at mentioned time points (both technical and clinical success)
次要结局
- Procedure duration(30 days)
- Health status(1 year, 5 years)
- Complications(30 days)
- Post procedural pain score(two weeks)
- Disease related quality of life(1 year, 5 years)
- Per-procedural pain score(two weeks)
- Costs of both treatments(1 year)
研究者
Michel Reijnen
Surgeon
Rijnstate Hospital