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

Varicose Veins of Lower Limb Clinical Trial

— FOVELASS  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05468450
• Other study ID #: 2014-A01943-44
• Status: Completed
• Phase: N/A
• Start date: July 1, 2015
• Est. completion date: August 31, 2016

Study information

• Verified date: July 2022
• Source: Societe Francaise de Phlebologie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 161
• Est. completion date: August 31, 2016
• Est. primary completion date: August 31, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Varicose Veins
• Varicose Veins of Lower Limb

Intervention

Drug:
• Ultrasound-guided-foam sclerotherapy (UGFS) using Polidocanol sclerosant
Direct injection Foam sclerotherapy

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)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Societe Francaise de Phlebologie

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absence of reflux in the treated SSV segment	closed veins or patent veins with no reflux (>0.5sec)	3Assessed at years
Secondary	Treatment time	Time (in minutes) spent in undertaking each treatment	Assessed on day of treatment
Secondary	Procedure related complications	Any related complications arising from the procedure	Assessed through study completion, an average of 3 years
Secondary	Periprocedural pain score	assessed on a visual analogue score (zero = no pain, 100 = maximum pain)	up to four weeks
Secondary	Presence of visible varices	Reported recurrence of varicose veins	Through study completion, average of 3 years
Secondary	Venous symptoms questionnaire	Validated questionnaire scores	Through study completion, average of 3 years
Secondary	Revised Venous Clinical Severity Score -rVCSS	Validated questionnaire scores	Through study completion, average of 3 years
Secondary	Quality of Life questionnaire (CIVIQ)	Validated questionnaire scores	Through study completion, average of 3 years