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

Societe Francaise de Phlebologie161 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

161

Conditions

Varicose Veins of Lower Limb

Interventions

Ultrasound-guided-foam sclerotherapy (UGFS) using Polidocanol sclerosantDRUG

Direct injection Foam sclerotherapy

Endovenous Laser Ablation (EVLA)DEVICE

EVLA using a 1470nm generator and 600-micron radial fibres (Biolitec® Biomedical Technology, Jena, Germany), under tumescent local anaesthesia (TLA)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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)

Outcomes

Primary Outcomes

Absence of reflux in the treated SSV segment

closed veins or patent veins with no reflux (\>0.5sec)

Time frame: 3Assessed at years

Secondary Outcomes

Treatment time

Time (in minutes) spent in undertaking each treatment

Time frame: Assessed on day of treatment

Procedure related complications

Any related complications arising from the procedure

Time frame: Assessed through study completion, an average of 3 years

Periprocedural pain score

assessed on a visual analogue score (zero = no pain, 100 = maximum pain)

Time frame: up to four weeks

Presence of visible varices

Reported recurrence of varicose veins

Time frame: Through study completion, average of 3 years

Venous symptoms questionnaire

Validated questionnaire scores

Time frame: Through study completion, average of 3 years

Revised Venous Clinical Severity Score -rVCSS

Validated questionnaire scores

Time frame: Through study completion, average of 3 years

Quality of Life questionnaire (CIVIQ)

Validated questionnaire scores

Time frame: Through study completion, average of 3 years

Data from ClinicalTrials.gov

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