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Completed

NCT Number: NCT05468450

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

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.

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Key information

Conditions

Varicose Veins of Lower Limb Cardiovascular Diseases Varicose Veins Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Drug

Direct injection Foam sclerotherapy

Other names: 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)

Other names: Laser therapy

Primary outcomes

  1. Absence of reflux in the treated SSV segment

    Time frame: 3Assessed at years

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

Secondary outcomes

  1. Treatment time

    Time frame: Assessed on day of treatment

    Time (in minutes) spent in undertaking each treatment

  2. Procedure related complications

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

    Any related complications arising from the procedure

  3. Periprocedural pain score

    Time frame: up to four weeks

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

  4. Presence of visible varices

    Time frame: Through study completion, average of 3 years

    Reported recurrence of varicose veins

  5. Venous symptoms questionnaire

    Time frame: Through study completion, average of 3 years

    Validated questionnaire scores

  6. Revised Venous Clinical Severity Score -rVCSS

    Time frame: Through study completion, average of 3 years

    Validated questionnaire scores

  7. Quality of Life questionnaire (CIVIQ)

    Time frame: Through study completion, average of 3 years

    Validated questionnaire scores

Sponsors and collaborators

Lead sponsor

Societe Francaise de Phlebologie

Other

Registry information

Official study 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)

Acronym: FOVELASS

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Jul 21, 2022
Registry last updated
Jul 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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