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

• Status: Completed
• Trial end date: 2016-08-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Societe Francaise de Phlebologie
• Treatments: Polidocanol; Sclerosing Solutions

Criteria

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)