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

Not Applicable

Completed

• Conditions: Varicose Veins of Lower Limb
• Interventions: Drug: Ultrasound-guided-foam sclerotherapy (UGFS) using Polidocanol sclerosant; Device: Endovenous Laser Ablation (EVLA)

• Registration Number: NCT05468450
• Lead Sponsor: Societe Francaise de Phlebologie

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.

Study Timeline

• Study Start: 2015-07-01
• Primary Completion: 2016-08-31
• Study Completion: 2016-08-31
• Status Verified: 2022-07
• Study First Submitted: 2022-07-13
• Study First Submitted QC: 2022-07-19
• Last Update Submitted: 2022-07-19
• Study First Posted: 2022-07-21
• Last Update Posted: 2022-07-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 161

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound-guided-foam sclerotherapy (UGFS)	Ultrasound-guided-foam sclerotherapy (UGFS) using Polidocanol sclerosant	Injection of Polidocanol foam into SSV
Endovenous Laser Ablation (EVLA)	Endovenous Laser Ablation (EVLA)	Ablation of SSV using laser energy

Primary Outcome Measures

Name	Time	Method
Absence of reflux in the treated SSV segment	3Assessed at years	closed veins or patent veins with no reflux (\>0.5sec)

Secondary Outcome Measures

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