Clinical trial NCT05468450: RCT Comparing EVLA Versus Polidocanol Foam in the Treatment of SSV Insufficiency
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Varicose Veins of Lower Limb
Keywords: small saphenous veins
varicose veins
ultrasound guided foam sclerotherapy
endovenous laser ablation
Lead sponsor: Societe Francaise de Phlebologie
Sponsor class: OTHER
First posted: 2022-07-21
Enrollment: 161
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: multicentre-RCT (11 centres) comparing ultrasound-guided-foam sclerotherapy (UGFS) and Endovenous Laser Ablation (EVLA) for treating small saphenous veins (SSV) insufficiency
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Absence of reflux in the treated SSV segment
timeFrame: 3Assessed at years
Secondary outcomes:
measure: Treatment time
timeFrame: Assessed on day of treatment
measure: Procedure related complications
timeFrame: Assessed through study completion, an average of 3 years
measure: Periprocedural pain score
timeFrame: up to four weeks
measure: Presence of visible varices
timeFrame: Through study completion, average of 3 years
measure: Venous symptoms questionnaire
timeFrame: Through study completion, average of 3 years
measure: Revised Venous Clinical Severity Score -rVCSS
timeFrame: Through study completion, average of 3 years
measure: Quality of Life questionnaire (CIVIQ)
timeFrame: Through study completion, average of 3 years
Other outcomes:
Locations:
Study officials:
affiliation: Institut des Varices- GHPJS Groupe Hospitalier
name: Claudine Hamel-Desnos
role: STUDY_DIRECTOR
affiliation: Société Française de Phlébologie
name: Matthieu Josnin
role: PRINCIPAL_INVESTIGATOR
References:
citation: 9) Hamel-Desnos C., Josnin M., Allaert F.-A. Etude contrôlée randomisée de l'efficacité du laser endoveineux (1470 nm) versus échosclérothérapie à la mousse dans le traitement de l'insuffisance de la petite veine saphène. Phlébologie 2019 (72): 8-18