Registry to Investigate the Efficacy and Safety of VenaBlock VeIn SEaling System for VaRicose Veins in SingApore
试验速览
- 阶段
- 不适用
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Occlusion of treated vein post-procedure
研究概览
简要总结
To assess the efficacy of the Venablock©Vein Sealing System (VBVS) 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 Registry to Investigate the Efficacy and Safety of Venablock©Vein Sealing System for Varicose Veins in Singapore (RIVERIA), is to investigate the performance of cyanoacrylate glue closure (CAC) using this device, in which multiple incompetent superficial saphenous truncal veins (great saphenous (GSV), short saphenous vein (SSV), anterior accessory saphenous vein (AASV) will be treated at the same setting, and compression stockings will not be used post-operatively. The inclusion criteria for this study will be liberalized, and veins up to 12mm in diameter will be treated. As such,RIVIERA will be the first prospective trial conducted in Asia on a predominantly Asian cohort of patients to report on the performance of Venablock© for blocking incompetent truncal veins. This study specifically focuses on the initial technical outcomes, safety, anatomical occlusion, and patient experience after treatment with Venablock© with broader inclusion of patients than previous caucasian based 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 ability to understand the requirements of the study and to provide informed consent
- •C2-C6 varicose veins/CVI (CEAP Class 1 patients will be excluded)
- •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
- •Pregnant patients
- •Arterial disease (ABPI<0.8)
- •Patient who are unwilling to participate
- •Inability or unwillingness to complete the time-point questionnaires
- •Adverse reaction to sclerosant or cyanoacrylate previously
- •Multiple drug allergies
- •Previous intervention with the VenaSeal cyanoacrylate glue closure system
- •Severely tortuous GSV, SSV or AASV
- •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
Occlusion of treated vein post-procedure
时间窗: Immediately post-op
Change in anatomy of treated vessel
时间窗: 2 weeks, 3 months, 6 months, 12 months post-procedure
Anatomical Success as measured at each timepoint using ultrasound to ensure occlusion of treated vessel. Recurrence or treatment failure will be defined as a re-opening of a segment \> 5cm in length.
次要结局
- Clinical Change using Venous Clinical Severity Score (VCSS)(2 weeks, 3 months, 6 months, 12 months post-procedure)
- Time taken to return to work and normal activities(Recorded 10 days post-procedure)
- Occlusion rates(2 weeks, 3 months, 6 months, 12 months post-procedure)
- Patient satisfaction with treatment: survey(2 weeks, 3 months, 6 months, 12 months post-procedure)
- Quality of Life Score using the Chronic Venous Insufficiency Questionnaire (CIVIQ)(2 weeks, 3 months, 6 months, 12 months post-procedure)
- Quality of Life score using the Aberdeen Varicose Vein Questionnaire (AVVQ)(2 weeks, 3 months, 6 months, 12 months post-procedure)
- Pain Score(First 10 days post-procedure)
- Cost effectiveness of the intervention(12 months post-procedure)
- Quality of Life Score using the EQ-5D questionnaire(2 weeks, 3 months, 6 months, 12 months post-procedure)