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

NCT05468450 | Completed

• 1 other identifier: 2014-A01943-44
• Study Type: interventional
• Target: 161
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Varicose Veins of Lower Limb

Keywords

small saphenous veins; varicose veins; ultrasound guided foam sclerotherapy; endovenous laser ablation

Outcome Measures

Primary Outcomes (1)

• Absence of reflux in the treated SSV segment

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

  3Assessed at years

Secondary Outcomes (7)

• Treatment time

  Assessed on day of treatment

• Procedure related complications

  Assessed through study completion, an average of 3 years

• Periprocedural pain score

  up to four weeks

• Presence of visible varices

  Through study completion, average of 3 years

• Venous symptoms questionnaire

  Through study completion, average of 3 years

Study Arms (2)

Ultrasound-guided-foam sclerotherapy (UGFS)

ACTIVE COMPARATOR

Injection of Polidocanol foam into SSV

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

Endovenous Laser Ablation (EVLA)

ACTIVE COMPARATOR

Ablation of SSV using laser energy

Device: Endovenous Laser Ablation (EVLA)

Interventions

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

Direct injection Foam sclerotherapy

Also known as: Foam sclerotherapy

Ultrasound-guided-foam sclerotherapy (UGFS)

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)

Also known as: Laser therapy

Endovenous Laser Ablation (EVLA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• Societe Francaise de Phlebologie: lead

Related Publications (2)

• 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

  BACKGROUND

• Hamel-Desnos C, Nyamekye I, Chauzat B, Gracia S, Josnin M, Abbadie F. FOVELASS: A Randomised Trial of Endovenous Laser Ablation Versus Polidocanol Foam for Small Saphenous Vein Incompetence. Eur J Vasc Endovasc Surg. 2023 Mar;65(3):415-423. doi: 10.1016/j.ejvs.2022.11.021. Epub 2022 Dec 5.

  PMID: 36470312 DERIVED

MeSH Terms

Conditions

Varicose Veins

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Claudine Hamel-Desnos

  Institut des Varices- GHPJS Groupe Hospitalier

  STUDY DIRECTOR

• Matthieu Josnin

  Société Française de Phlébologie

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Blinding of participants and investigators is not possible because of the obvious differences between the two treatments (a single mid-calf injection versus multiple injections for tumescent anaesthesia/laser precautions etc…). A blind third-party check was carried out, only at 3 years, and those assessors were completely independent of the study and blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: multicentre-RCT (11 centres) comparing ultrasound-guided-foam sclerotherapy (UGFS) and Endovenous Laser Ablation (EVLA) for treating small saphenous veins (SSV) insufficiency

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 21, 2022
• Study Start: July 1, 2015
• Primary Completion: August 31, 2016
• Study Completion: August 31, 2016
• Last Updated: July 21, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share