Varicose Veins of Lower Limb Clinical Trial
— FOVELASSOfficial 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)
Verified date | July 2022 |
Source | Societe Francaise de Phlebologie |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
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Societe Francaise de Phlebologie |
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
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 |
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