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

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)

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.

Study Overview

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

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 Type: Interventional
• Enrollment (Actual): 161
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Ultrasound-guided-foam sclerotherapy (UGFS); Injection of Polidocanol foam into SSV	Drug: Ultrasound-guided-foam sclerotherapy (UGFS) using Polidocanol sclerosant; Direct injection Foam sclerotherapy; Other Names: Foam sclerotherapy
Active Comparator: Endovenous Laser Ablation (EVLA); Ablation of SSV using laser energy	Device: Endovenous Laser Ablation (EVLA); EVLA using a 1470nm generator and 600-micron radial fibres (Biolitec® Biomedical Technology, Jena, Germany), under tumescent local anaesthesia (TLA); Other Names: Laser therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Absence of reflux in the treated SSV segment	closed veins or patent veins with no reflux (>0.5sec)	3Assessed at years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Societe Francaise de Phlebologie
• Investigators: Study Director: Claudine Hamel-Desnos, Institut des Varices- GHPJS Groupe Hospitalier; Principal Investigator: Matthieu Josnin, Société Française de Phlébologie

Publications and helpful links

General Publications

• 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

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): August 31, 2016
• Study Completion (Actual): August 31, 2016

Study Registration Dates

• First Submitted: July 13, 2022
• First Submitted That Met QC Criteria: July 19, 2022
• First Posted (Actual): July 21, 2022

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 19, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: varicose veins; endovenous laser ablation; small saphenous veins; ultrasound guided foam sclerotherapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicose Veins; Pharmaceutical Solutions; Polidocanol; Sclerosing Solutions
• Other Study ID Numbers: 2014-A01943-44

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: Randomised is provided by the independent statistics centre (Cenbiotech; Dijon-France), who also analysed IPD. Investigators cannot access other centres' data.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No