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Study on Treatment of Varicose Veins by Endovenous Laser (1940 nm vs 1470 nm)

ConditionVaricose Veins
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorClinique Pasteur

About this trial

The goal of this clinical trial is to compare efficacy of two wavelength for EndoVenous Laser Ablation (EVLA) in treatment of varicose veins of the lower limbs.

The main questions it aims to answers are :

1. Is the increase of wavelength form 1470 nm to 1940 nm affect the efficacy of varicose veins treatment ? 2. Is the increase of wavelength reduce complication or pain ? Participants are patients with varicose veins of lower limbs and candidate for endovenous laser ablation.

After laser ablation patients will be followed during 5 years for clinical evaluation, recording potential treatment complications and quality of life evaluation.

Researchers will compare strategy 1(EVLA with an endovenous laser at 1940 nm) vs strategy 2 (EVLA with an endovenous laser at 1470 nm) in varicose veins treatment to see if efficacy of treatment is not reduce, and to see if complications of EVLA treatment can be reduced.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Primary insufficiency of the great saphenous vein (GSV) and/or small saphenous vein (SSV)

Patient candidate for endothermic treatment of the lower limbs

CEAP: C2 - C6

Patient with a target vein diameter (GSV and/or SSV) >= 3 mm throughout the target vein segment

Disqualifiers

Patient with a current serious pathology and/or a life expectancy of less than 5 years

Patient who has had a deep or superficial vein thrombosis in the previous 6 months

Obliterating arteriopathy of the lower limb concerned, with an IPS < 0.8 or > 1.3

Patient with post-thrombotic obstructive syndrome at the popliteal and/or femoral and/or iliac stage on the ipsilateral lower limb

Trial design

Design model

Parallel

Treatments tested in this trial

  • EVLA 1940 nm

    Procedure/Surgery

    Treatment of varicose veins by endothermic ablation with an endovenous laser at 1940 nm

  • EVLA 1470 nm

    Procedure/Surgery

    Treatment of varicose veins by endothermic ablation with an endovenous laser at 1470 nm

Treatment groups

280 Participants
are divided into 2 treatment groups
Group A: 1940 nmActive comparator 1 intervention
Group B: 1470 nmActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Anatomical success

Closure of the target vein

Time frame
At 5 years

Secondary outcomes

1

VAS Pain

Visual Analogue Scale (0-100 mm); higher is worse

Time frame
Day 0, Day 8, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
2

Adverse Events

Adverse events related to endovenous treatment

Time frame
Day 0, Day 8, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
3

Venous Clinical Severity

Venous Clinical Severity Score (VCSS) ; score between 0 to 30; higher is worse

Time frame
Day 0, Day 8, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
4

Symptoms

VEINES Sym (VEnous INsufficiency Epidemiologic and Economic Study - Symptoms) questionnaire

Time frame
Day 0, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Clinique Pasteur

Lead sponsor

Source ClinicalTrials.gov
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