Randomised Controlled Trial of Mechanochemical Ablation Versus Cyanoacrylate Adhesive for the Treatment of Varicose Veins
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 167
- 试验地点
- 2
- 主要终点
- Pain Score During Ablation
研究概览
简要总结
This study will be comparing the treatment of varicose veins using either mechanochemical ablation (MOCA) or cyanoacrylate adhesive (CAE). Patients will be randomised to receiving either MOCA or CAE.
The pain scores, clinical scores, quality of life scores, occlusion and re-intervention rate at 2 weeks, 3, 6 and 12 months as well as the cost effectiveness of each intervention will be assessed.
详细描述
This will be a randomised clinical trial comparing MOCA to CAE. Patients will be randomised into group A (MOCA) or group B (CAE). Only the endovenous ablation part of the procedure will be randomised while the decision as to whether patients should receive treatment of their varicose tributaries will be at the discretion of the clinical team.
The device used for MOCA (group A) will be the ClariVein® mechanochemical ablation (MOCA) device (Vascular Insights, Madison, CT, USA).
The device used for CAE (group B) will be the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA).
Re-intervention of the treated saphenous veins will not be decided until at least 3 months after their initial procedure.
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
- Double (Participant, Outcomes Assessor)
盲法说明
An internet-based randomisation service will be used Outcome assessors will be blinded as to treatment offered
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
- •Adults over 18 years of age
- •Symptomatic GSV or SSV vein reflux > 0.5 seconds on colour Duplex
排除标准
- •Current DVT
- •Recurrent varicose veins
- •Arterial disease (ABPI<0.8)
- •Vein diameter < 3mm
- •Patient who are unwilling to participate
- •Inability or unwillingness to complete questionnaires
- •Adverse reaction to sclerosant or cyanoacrylate
- •Not been involved in another venous trial for at least 6 months
结局指标
主要结局
Pain Score During Ablation
时间窗: On day 0 immediately following vein ablation
Pain score during saphenous vein ablation using a 0-100mm visual analogue scale (0=no pain; 100=worst pain)
次要结局
- Degree of Bruising at 2 Weeks(2 weeks)
- Pain Score at the End of the Procedure(On day 0 following vein ablation and any tributary treatment)
- Occlusion Rates(12 months)
- Disease Specific Quality of Life as Per the CIVIQ-20(12 months)
- Clinical Change as Per VCSS(12 months)
- Generic Quality of Life as Per EQ-5D Questionnaire(Recorded at 12 months)
- Disease Specific Quality of Life as Per the AVVQ(Recorded at 12 months)
- Pain Score Over the First 10 Days(For the first 10 days since procedure)
- Time to Return to Normal Activities(2 weeks)