Chronic Venous Insufficiency, Varicose Veins, Venous Reflux
Conditions
Keywords
Endovenous Ablation
Brief summary
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
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.
Interventions
OTHERQuestionnaires
Questionnaires to assess quality of life
Sponsors
Singapore General Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
21 Years to 90 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Technical Success at time of procedure | Immediately post-op | Occlusion of treated vein post-procedure |
| Change in anatomy of treated vessel | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life score using the Aberdeen Varicose Vein Questionnaire (AVVQ) | Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation | 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 |
| Clinical Change usin Venous Clinical Severity Score (VCSS) | Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation | VCSS evaluates the severity of hallmarks of venous disease - 0 (none), 1 (mild), 2 (moderate), 3 (severe). |
| Pain Score | First 10 days post-operation | Using a numerical rating scale, which ranges from 0 (no pain) to 10 (severe pain) |
| Quality of Life Score using the EQ-5D questionnaire | Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation | 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. |
| Occlusion rates | 2 weeks, 3 months, 6 months and 12 months post-operation | Duplex ultrasound performed at specific timepoints to ensure that treated vein is occluded |
| Patient satisfaction with treatment | 2 weeks, 3 months, 6 months and 12 months post-procedure | A short survey to assess patient satisfaction and if there are any observed improvement in terms of appearance and symptoms post-procedure. |
| Cost Effectiveness of the intervention | 12 months post-procedure | To evaluate the cost involved with procedure performed |
| Time taken to return to work and normal activities | 10 days post-op | — |
| Quality of Life Score using the Chronic Venous Insufficiency Questionnaire (CIVIQ) | Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation | 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. |
Countries
Singapore
Outcome results
None listed