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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

161 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-01

Study Completion Date

2016-08-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Varicose Veins of Lower Limb

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

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.

Study Groups

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Ultrasound-guided-foam sclerotherapy (UGFS)

Injection of Polidocanol foam into SSV

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

Direct injection Foam sclerotherapy

Endovenous Laser Ablation (EVLA)

Ablation of SSV using laser energy

Group Type ACTIVE_COMPARATOR

Endovenous Laser Ablation (EVLA)

Intervention Type DEVICE

EVLA using a 1470nm generator and 600-micron radial fibres (Biolitec® Biomedical Technology, Jena, Germany), under tumescent local anaesthesia (TLA)

Interventions

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

Direct injection Foam sclerotherapy

Intervention Type DRUG

Endovenous Laser Ablation (EVLA)

EVLA using a 1470nm generator and 600-micron radial fibres (Biolitec® Biomedical Technology, Jena, Germany), under tumescent local anaesthesia (TLA)

Intervention Type DEVICE

Other Intervention Names

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Foam sclerotherapy Laser therapy

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No