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

Societe Francaise de Phlebologie

Status: Completed

Conditions: Varicose Veins of Lower Limb

Treatments: Device: Endovenous Laser Ablation (EVLA); Drug: Ultrasound-guided-foam sclerotherapy (UGFS) using Polidocanol sclerosant

Study type: Interventional

Funder types: Other

Identifiers

NCT05468450

2014-A01943-44

Details and patient eligibility

About

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.

Full 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.

Enrollment: 161 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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161 participants in 2 patient groups

Ultrasound-guided-foam sclerotherapy (UGFS)

Active Comparator group

Description:

Injection of Polidocanol foam into SSV

Treatment:

Drug: Ultrasound-guided-foam sclerotherapy (UGFS) using Polidocanol sclerosant

Endovenous Laser Ablation (EVLA)

Active Comparator group

Description:

Ablation of SSV using laser energy

Treatment:

Device: Endovenous Laser Ablation (EVLA)