A Singapore Venaseal Real World Post-Market Evaluation Study

Singapore General Hospital100 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Varicose Veins Venous Reflux Chronic Venous Insufficiency

Interventions

QuestionnairesOTHER

Questionnaires to assess quality of life

Eligibility

Sex: ALLMin age: 21 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (2)

Singapore General Hospital

Singapore, Singapore

Sengkang General Hospital

Singapore, Singapore

Outcomes

Primary Outcomes

Technical Success at time of procedure

Occlusion of treated vein post-procedure

Time frame: 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

Time frame: 2 weeks, 3 months, 6 months and 12 months post-procedure

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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

Time frame: Baseline, 2 weeks, 3 months, 6 months and 12 months post-operation

Clinical Change usin Venous Clinical Severity Score (VCSS)

Data from ClinicalTrials.gov

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