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

NCT05663359 | Recruiting

• 1 other identifier: 2022-A01722-41
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 1

Brief 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. 1.Is the increase of wavelength form 1470 nm to 1940 nm affect the efficacy of varicose veins treatment ?
2. 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.

Conditions

Varicose Veins

Keywords

Endovenous laser ablation (EVLA)

Outcome Measures

Primary Outcomes (1)

• Anatomical success

  Closure of the target vein

  At 5 years

Secondary Outcomes (6)

• VAS Pain

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

• Adverse Events

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

• Venous Clinical Severity

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

• Symptoms

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

• Patient quality of life (1)

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

Study Arms (2)

1940 nm

ACTIVE COMPARATOR

Endovenous laser at 1940 nm

Procedure: EVLA 1940 nm

1470 nm

ACTIVE COMPARATOR

Endovenous laser at 1470 nm

Procedure: EVLA 1470 nm

Interventions

EVLA 1940 nm PROCEDURE

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

1940 nm

EVLA 1470 nm PROCEDURE

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

1470 nm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Clinique Pasteur: lead

Study Sites (1)

Clinique Pasteur

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Nicolas NEAUME, MD

  Clinique Pasteur

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nicolas NEAUME, MD

CONTACT

+33 5 61 16 13 03; nneaume@clinique-pasteur.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: December 23, 2022
• Study Start: February 24, 2023
• Primary Completion (Estimated): February 1, 2032
• Study Completion (Estimated): February 1, 2032
• Last Updated: March 6, 2026

Record last verified: 2026-03

Locations

FR (1)