A Singapore Venaseal Real World Post-Market Evaluation Study

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Multi-Centre Registry to Investigate the Efficacy and Safety of Venaseal Endovenous Ablation for Varicose Veins in Singapore

Conditions
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Varicose Veins, Venous Reflux, Chronic Venous Insufficiency

Intervention / Treatment
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* Other: Questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: Current DVT or history of DVT Recurrent varicose veins Pregnant patients Arterial Disease (ABPI<0.8) Sepsis 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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Venaseal<br>Patients that have undergone venaseal | Other: Questionnaires<br>* Questionnaires to assess quality of life<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical Success at time of procedure | Occlusion of treated vein post-procedure | Immediately post-op | 
| Change in anatomy of treated vessel | Anatomical Success as measured at each timepoint using ultrasound to ensure no re-opening of treated vessel | 2 weeks, 3 months, 6 months and 12 months post-procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life Score using the EQ-5D questionnaire | EQ5D is used to assess quality of life based on Mobility, Self-Care, Usual Activities, Pain/Discomfort and Anxiety, rated at 5 levels: no problems, slight problems, moderate problems, severe problems, unable to perform activity. Inputs from this questionnaire is used to observe for changes in quality of life overtime. | Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation | 
| Quality of Life Score using the Chronic Venous Insufficiency Questionnaire (CIVIQ) | CIVIQ is a questionnaire based on three dimensions - pain, physical and psychological, based on a scale from 1 to 5 (no trouble, slight, moderate, considerable, severe). Based on inputs, Global Index Score (GIS) will be tabulated, ranging for 0 to 100 - the higher the value, the poorer the quality of life. | Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation | 
| Quality of Life score using the Aberdeen Varicose Vein Questionnaire (AVVQ) | To measure health status of varicose veins patients based on symptoms and impact on daily activities. A total score ranging from 0 to 100 will be tabulated, with 100 being worst quality of life | Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation | 
| Clinical Change usin Venous Clinical Severity Score (VCSS) | VCSS evaluates the severity of hallmarks of venous disease - 0 (none), 1 (mild), 2 (moderate), 3 (severe). | Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation | 
| Pain Score | Using a numerical rating scale, which ranges from 0 (no pain) to 10 (severe pain) | First 10 days post-operation | 
| Time taken to return to work and normal activities |  | 10 days post-op | 
| Occlusion rates | Duplex ultrasound performed at specific timepoints to ensure that treated vein is occluded | 2 weeks, 3 months, 6 months and 12 months post-operation | 
| Patient satisfaction with treatment | A short survey to assess patient satisfaction and if there are any observed improvement in terms of appearance and symptoms post-procedure. | 2 weeks, 3 months, 6 months and 12 months post-procedure | 
| Cost Effectiveness of the intervention | To evaluate the cost involved with procedure performed | 12 months post-procedure | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Endovenous Ablation