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

Varicose Veins Clinical Trial

— NEWWAVE  

Official title:

Randomized Comparative Study With Two Wavelengths 1470 nm and 1940 nm for the Treatment of Varicose Veins of the Lower Limbs by Endovenous Laser.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05663359
• Other study ID #: 2022-A01722-41
• Status: Recruiting
• Phase: N/A
• Start date: February 24, 2023
• Est. completion date: February 2031

Study information

• Verified date: February 2024
• Source: Clinique Pasteur
• Contact: Nicolas NEAUME, MD
• Phone: +33 5 61 16 13 03
• Email: nneaume[@]clinique-pasteur.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: February 2031
• Est. primary completion date: February 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

• Patient affiliated or beneficiary of a social security scheme

• Patient having signed the informed consent

Exclusion Criteria:

• 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

• Patient with primary or post-thrombotic axial deep venous reflux on the ipsilateral lower limb

• Suspicion of non-post-thrombotic iliac compression on echo-doppler

• Contraindication to the planned treatment technique

• Patient whose geographical distance is not compatible with the follow-up of the study

• Pregnant or breastfeeding women

• Patient linguistically or psychologically unable to understand the information given, to give informed consent or to answer the study questionnaires.

• Protected patients: Adults under guardianship, or other legal protection; Hospitalized without consent.

Related Conditions & MeSH terms

• Varicose Veins

Intervention

Procedure:
• EVLA 1940 nm
Treatment of varicose veins by endothermic ablation with an endovenous laser at 1940 nm
• EVLA 1470 nm
Treatment of varicose veins by endothermic ablation with an endovenous laser at 1470 nm

Locations

Country	Name	City	State
France	Clinique Pasteur	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
Clinique Pasteur

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Anatomical success	Closure of the target vein	At 5 years
Secondary	VAS Pain	Visual Analogue Scale (0-100 mm); higher is worse	Day 0, Day 8, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Secondary	Adverse Events	Adverse events related to endovenous treatment	Day 0, Day 8, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Secondary	Venous Clinical Severity	Venous Clinical Severity Score (VCSS) ; score between 0 to 30; higher is worse	Day 0, Day 8, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Secondary	Symptoms	VEINES Sym (VEnous INsufficiency Epidemiologic and Economic Study - Symptoms) questionnaire	Day 0, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Secondary	Patient quality of life (1)	VEINES Sym (VEnous INsufficiency Epidemiologic and Economic Study - quality of life ) questionnaire	Day 0, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5
Secondary	Patient quality of life (2)	EuroQol-5 Dimension (EQ5D) Quality of life survey	Day 0, Month 6, Year 1, Year 2, Year 3, Year 4, Year 5