Multi-Centre Registry to Investigate the Efficacy and Safety of Venaseal Endovenous Ablation for Varicose Veins in Singapore
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Technical Success at time of procedure
研究概览
简要总结
The study aims to assess the efficacy of VenaSeal™ Closure System (VCS) for the treatment of lower extremity superficial truncal veins in a real-world clinical setting, in a multi-racial Asian population in Singapore.
详细描述
The purpose of the ASVS study is to investigate the performance of cyanoacrylate glue closure (CAC) in a real-world post market evaluation setting in which multiple incompetent superficial saphenous truncal veins - namely (great saphenous vein (GSV), short saphenous vein (SSV), anterior accessory saphenous vein (AASV) - will be treated at the same setting, and compression stockings will not be used postoperatively. Unlike previous studies, the inclusion criteria for this study will be liberalized, and veins up to 12mm in diameter will be treated. As such, ASVS will be the first published prospective trial conducted in Asia on a predominantly Asian cohort of patients to report on the performance of CAC for incompetent GSV and non-GSV trunks. This study specifically focuses on the initial technical outcomes, safety, anatomical occlusion and patient experience with CAC applied with broader inclusion of patients than previous trials.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 21 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 21 years old and able to understand the requirements of the study and to provide informed consent
- •C2 - C5 symptomatic veins / Chronic Venous Insufficiency
- •Symptomatic primary GSV, SSV or AASV incompetence, with reflux > 0.5 seconds on colour Duplex, including one or more of the following symptoms: aching, throbbing, heaviness, fatigue, pruritus, night cramps, restlessness, generalized pain or discomfort, swelling
- •Patients who had GSV, SSV or AASV diameters of 3mm to 12mm in the standing position
排除标准
- •Current DVT or history of DVT
- •Recurrent varicose veins
- •Pregnant patients
- •Arterial Disease (ABPI<0.8)
- •Patients who are unwilling to participate
- •Inability or unwillingness to complete questionnaires
- •Adverse reaction to sclerosant or cyanoacrylate
- •GSV, SSV or AASV severely tortuous
- •Life expectancy < 1 year
- •Active treatment for malignancy other than non-melanoma skin cancer
- •Current, regular use of systemic anticoagulation (e.g. warfarin, heparin)
- •Daily use of narcotic analgesia or NSAIDS to control pain associated with venous disease
结局指标
主要结局
Technical Success at time of procedure
时间窗: Immediately post-op
Occlusion of treated vein post-procedure
Change in anatomy of treated vessel
时间窗: 2 weeks, 3 months, 6 months and 12 months post-procedure
Anatomical Success as measured at each timepoint using ultrasound to ensure no re-opening of treated vessel
次要结局
- Quality of Life Score using the EQ-5D questionnaire(Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation)
- Quality of Life Score using the Chronic Venous Insufficiency Questionnaire (CIVIQ)(Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation)
- Quality of Life score using the Aberdeen Varicose Vein Questionnaire (AVVQ)(Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation)
- Clinical Change usin Venous Clinical Severity Score (VCSS)(Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation)
- Pain Score(First 10 days post-operation)
- Time taken to return to work and normal activities(10 days post-op)
- Occlusion rates(2 weeks, 3 months, 6 months and 12 months post-operation)
- Patient satisfaction with treatment(2 weeks, 3 months, 6 months and 12 months post-procedure)
- Cost Effectiveness of the intervention(12 months post-procedure)