Varicose Veins, Varicose Veins of Leg With Long Saphenous Vein Distribution
Conditions
Keywords
endovenous laser ablation, endovenous steam ablation, great saphenous veins, quality of life
Brief summary
Endovenous laser ablation is a common therapy of great saphenous vein insufficiency with a very high success rate. It works by heating and thereby obliterating the vein. Steam ablation is a new therapy that also works by heating and thereby obliterating the vein. The hypothesis of this study is that steam ablation is as effective as laser ablation, but that it results in better secondary outcomes (e.g., lower pain scores).
Detailed description
The study is a randomized clinical trial comparing two different therapies for endovenous ablation of great saphenous veins. The aim of the study is to test whether the anatomical success rate of Steam Ablation is not inferior to that of Endovenous laser ablation (EVLA) in treatment of great saphenous vein insufficiency and compare the treatment safety, patient reported outcomes and cost-effectiveness analyses between EVLA and Steam Ablation.
Interventions
PROCEDUREEndovenous laser ablation with 940 nm bare fiber
Endovenous laser ablation with 940 nm Diode laser using a bare fiber for treating the Great Saphenous Vein.
PROCEDUREEndovenous steam ablation with steam vein sclerosis system.
Endovenous steam ablation with steam vein sclerosis.
Sponsors
Erasmus Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients over 18 years old * Insufficiency of the GSV measured with ultrasound imaging, reflux \> 0.5 s, and diameter of vein \> 0.5 cm * Symptoms of chronic venous insufficiency * No prior treatment of the insufficient GSV * Informed consent
Exclusion criteria
* Acute deep or superficial vein thrombosis * Agenesis of deep vein system * Vascular malformation or syndrome * Post-thrombotic syndrome, occlusive type * Pregnancy * Immobility * Allergy to lidocaine * Arterial insufficiency
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Obliteration of varicose vein and/ or absence of reflux (>0.5 sec. of retrograde flow over >10cm) along the treated segment of the great saphenous vein (GSV) at 12 and 52 weeks. | 52 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Major complications: deep and superficial venous thrombosis (embolic events), nerve injury, skin burns, and (sub)cutaneous infections. | 12 weeks |
| Minor complications: ecchymosis, pain and hyperpigmentation. | 12 weeks |
| Venous Clinical Severity Score (VCSS) | 12 weeks |
| Treatment satisfaction | 2 weeks |
| Pain score | 2 weeks |
| Health related quality of life will be measured using the Dutch Translated Aberdeen Varicose Vein Questionnaire (AVVQ). | 12 weeks |
Countries
Netherlands
Outcome results
None listed