Vacuum-assisted Laser Ablation (VALA) for Treatment of Large Saphenous Veins

NCT06971068 | Recruiting

• 1 other identifier: CenterPhlebology
• Study Type: interventional
• Target: 184
• Locations: 4 countries
• Sites: 9

Brief Summary

Endovenous thermal ablation (EVTA), including radiofrequency ablation (RFA) and endovenous laser ablation (EVLA), is considered the main method for the treatment of symptomatic truncal vein reflux. However, there are controversial data concerning their efficacy and safety in ablating large saphenous veins because of high risk of heat-induced thrombosis (EHIT), incomplete ablation and recanalization.1-5 The use of vacuum evacuation of the remaining intraluminal blood during endovenous laser ablation allows to decrease the risk of intraoperative (carbonization and destruction of the fiber lens) and postoperative complications (EHIT, hyperpigmentation, "string" feeling) and leads to reduction of recovery because of short period of vein resorption. The aim of the study is to evaluate the safety and effectiveness of endovenous thermal ablation with or without vacuum evacuation for the treatment of incompetent large saphenous veins (\>15 mm).

Conditions

Varicose Veins

Keywords

Vacuum-assisted Laser Ablation; large saphenous veins; varicose veins; EVLA

Outcome Measures

Primary Outcomes (1)

• Occlusion of the treated GSV/SSV

  Obliteration of varicose vein along the treated segment of the GSV/SSV measured using ultrasound (US) examination

  One day, 2 weeks, one month, 3 months and 6 months post treatment

Secondary Outcomes (7)

• Pain score and use of painkillers

  One day, 2 weeks, one month, 3 months and 6 months post treatment

• Clinical status

  2 weeks, one month, 3 months and 6 months post treatment

• Severity of chronic venous diseases

  2 weeks, one month, 3 months and 6 months post treatment

• Health related quality of life

  one month, 3 months and 6 months post treatment

• Histological picture of the treated vein

  2 weeks, one month, 3 months post treatment

Study Arms (2)

Radial 2ring fiber

ACTIVE COMPARATOR

Refluxing GSV/SSV treated with endovenous laser ablation using ELVeS Radial 2ring fiber

Procedure: Procedure: EVLA

Radial 2ring Pro fiber

ACTIVE COMPARATOR

Refluxing GSV/SSV treated with endovenous laser ablation using ELVeS Radial 2ring Pro fiber

Procedure: Procedure: VALA

Interventions

Procedure: EVLA PROCEDURE

Great or small saphenous vein occlusion with endovenous laser ablation using ELVeS Radial 2ring fiber

Radial 2ring fiber

Procedure: VALA PROCEDURE

Great or small saphenous vein occlusion with endovenous laser ablation using ELVeS Radial 2ring Pro fiber

Radial 2ring Pro fiber

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age over 18 years
• Varicose veins of the lower extremities with clinical class C2-C6 with a diameter of the GSV or SSV ≥ 15 mm in a standing position
• Informed consent

You may not qualify if:

• pregnancy or lactation
• malignant neoplasms
• inability or unwillingness of any patient to wear compression stockings
• hypersensitivity to lidocaine
• concomitant diseases: diabetes mellitus, bronchial asthma, severe liver and kidney diseases, acute thrombosis and thrombophlebitis, skin and/or soft tissue infection, infectious diseases, obliterating peripheral arteriosclerosis, diabetic angiopathy, heart defects requiring surgical intervention, fever, toxic hyperthyroidism, obesity, tuberculosis, sepsis, blood cell composition disorder, all diseases requiring bed rest, heart disease with decompensation, known hereditary thrombophilia
• period after treatment for alcohol addiction
• sedentary lifestyle
• history of acute deep vein thrombosis
• history of superficial thrombophlebitis
• history of drug or other addiction
• use of oral contraceptives or other hormonal drugs

Sponsors & Collaborators

• Center Of Phlebology: lead

Study Sites (9)

Clinic in Uruchye

Minsk, Belarus

RECRUITING

Merci clinic

Minsk, Belarus

RECRUITING

SANTE clinic

Minsk, Belarus

RECRUITING

Center Of Phlebology

Bishkek, Chuy Region, 720023, Kyrgyzstan

RECRUITING

Laser Surgery Center

Moscow, Russia

RECRUITING

Innovative vascular centre

Saint Petersburg, Russia

RECRUITING

Derzhavin Tambov State University

Tambov, 392002, Russia

RECRUITING

Clinic of Modern Phlebology "VarikozOFF"

Tashkent, Uzbekistan

RECRUITING

Clinic of Modern Phlebology "VarikozOFF"

Tashkent, Uzbekistan

RECRUITING

Related Publications (5)

• Van der Velden SK, Lawaetz M, De Maeseneer MG, Hollestein L, Nijsten T, van den Bos RR; Members of the Predictors of Endovenous Thermal Ablation Group. Predictors of Recanalization of the Great Saphenous Vein in Randomized Controlled Trials 1 Year After Endovenous Thermal Ablation. Eur J Vasc Endovasc Surg. 2016 Aug;52(2):234-41. doi: 10.1016/j.ejvs.2016.01.021. Epub 2016 Mar 16.

  PMID: 26994834 BACKGROUND

• Sufian S, Arnez A, Labropoulos N, Lakhanpal S. Endovenous heat-induced thrombosis after ablation with 1470 nm laser: Incidence, progression, and risk factors. Phlebology. 2015 Jun;30(5):325-30. doi: 10.1177/0268355514526588. Epub 2014 Mar 7.

  PMID: 24609619 BACKGROUND

• Bontinis V, Bontinis A, Koutsoumpelis A, Potouridis A, Giannopoulos A, Rafailidis V, Chorti A, Ktenidis K. Endovenous thermal ablation in the treatment of large great saphenous veins of diameters > 12 mm: A systematic review meta-analysis and meta-regression. Vasc Med. 2023 Oct;28(5):449-457. doi: 10.1177/1358863X231183997. Epub 2023 Jul 17.

  PMID: 37458188 BACKGROUND

• Elboushi A, Elsherbeni M, Gameel AM, et al. The 1470 radial endovenous laser ablation of the great saphenous vein larger than 12 mm: Is it a good option? A single-center expe-rience? Egyptian J Surg 2019; 38: 136-141.

  BACKGROUND

• Dabbs EB, Mainsiouw LE, Holdstock JM, Price BA, Whiteley MS. A description of the 'smile sign' and multi-pass technique for endovenous laser ablation of large diameter great saphenous veins. Phlebology. 2018 Sep;33(8):534-539. doi: 10.1177/0268355517734480. Epub 2017 Sep 28.

  PMID: 28956693 BACKGROUND

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Dmitrii N Alekseev, PhD

CONTACT

+996555521274; dm.alekseev81@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: May 2, 2025
• First Posted: May 14, 2025
• Study Start: March 15, 2025
• Primary Completion: September 15, 2025
• Study Completion: February 15, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: From 15 March 2025 to 15 February 2026

Locations

BE (3); KY (1); RU (3); UZ (2)