Multi-Centre Registry to Investigate the Efficacy and Safety of Venaseal Endovenous Ablation for Varicose Veins in Singapore
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Varicose Veins
- Sponsor
- Singapore General Hospital
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Technical Success at time of procedure
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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)
- •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
Outcomes
Primary Outcomes
Technical Success at time of procedure
Time Frame: Immediately post-op
Occlusion of treated vein post-procedure
Change in anatomy of treated vessel
Time Frame: 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 Outcomes
- 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)