RCT Comparing EVLA Versus Polidocanol Foam in the Treatment of SSV Insufficiency

Study Overview
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Brief Summary
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FOVELASS is a multicentre-RCT (11 centres) comparing ultrasound-guided-foam sclerotherapy (UGFS) and Endovenous Laser Ablation (EVLA) for treating SSV insufficiency, conducted by the French Society of Phlebology.

Detailed Description
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Saphenous vein insufficiency is a common finding in varicose veins cases. International guidelines currently recommend endovenous thermal ablation using laser (EVLA) or radiofrequency as first line treatment for truncal Great Saphenous Vein (GSV) incompetence in preference to Ultrasound Guided Foam Sclerotherapy (UGFS) (1,2). This GSV-based recommendation has tended to be used for treating Small Saphenous Vein (SSV) incompetence. To date, no RCTs have directly compared UGFS and EVLA for SSV treatment. The French Society of Phlebology (SFP) decided to compare these two most utilised endovenous treatments in France in a controlled study called the FOam VErsus LAser in the SSv (FOVELASS) study, involving 13 investigators in 11 vascular medical centres.

Official Title
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Three-year Outcomes of a RCT Comparing EVLA Versus Polidocanol Foam in the Treatment of SSV Insufficiency (FOVELASS Study, by the French Society of Phlebology)

Conditions
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Varicose Veins of Lower Limb

Intervention / Treatment
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* Drug: Ultrasound-guided-foam sclerotherapy (UGFS) using Polidocanol sclerosant
* Device: Endovenous Laser Ablation (EVLA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: symptomatic varicose veins (CEAP C2s-C6) underlying isolated SSV incompetence (SSV reflux time>0.5sec on duplex ultrasound (DUS)) reflux involving at least 15 cm of proximal SSV minimal SSV diameter of 4 mm at mid-calf (luminal diameter in standing position) Exclusion Criteria: SSV treatment in the preceding 3 months post-thrombotic disease deep or superficial vein thrombosis of less than 3 months duration coexistent ipsilateral GSV insufficiency morbid obesity (BMI>40) presence of significant arterial disease (ABPI<0.5)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: multicentre-RCT (11 centres) comparing ultrasound-guided-foam sclerotherapy (UGFS) and Endovenous Laser Ablation (EVLA) for treating small saphenous veins (SSV) insufficiency
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultrasound-guided-foam sclerotherapy (UGFS)<br>Injection of Polidocanol foam into SSV | Drug: Ultrasound-guided-foam sclerotherapy (UGFS) using Polidocanol sclerosant<br>* Direct injection Foam sclerotherapy<br>* Other names: Foam sclerotherapy;|
| Active Comparator: Endovenous Laser Ablation (EVLA)<br>Ablation of SSV using laser energy | Device: Endovenous Laser Ablation (EVLA)<br>* EVLA using a 1470nm generator and 600-micron radial fibres (Biolitec® Biomedical Technology, Jena, Germany), under tumescent local anaesthesia (TLA)<br>* Other names: Laser therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absence of reflux in the treated SSV segment | closed veins or patent veins with no reflux (>0.5sec) | 3Assessed at years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment time | Time (in minutes) spent in undertaking each treatment | Assessed on day of treatment | 
| Procedure related complications | Any related complications arising from the procedure | Assessed through study completion, an average of 3 years | 
| Periprocedural pain score | assessed on a visual analogue score (zero = no pain, 100 = maximum pain) | up to four weeks | 
| Presence of visible varices | Reported recurrence of varicose veins | Through study completion, average of 3 years | 
| Venous symptoms questionnaire | Validated questionnaire scores | Through study completion, average of 3 years | 
| Revised Venous Clinical Severity Score -rVCSS | Validated questionnaire scores | Through study completion, average of 3 years | 
| Quality of Life questionnaire (CIVIQ) | Validated questionnaire scores | Through study completion, average of 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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small saphenous veins, varicose veins, ultrasound guided foam sclerotherapy, endovenous laser ablation