Health Trials

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

ConditionVaricose Veins
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-90
SponsorCenter Of Phlebology

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

pregnancy or lactation

malignant neoplasms

inability or unwillingness of any patient to wear compression stockings

hypersensitivity to lidocaine

Trial design

Design model

Parallel

Treatments tested in this trial

  • Procedure: EVLA

    Procedure/Surgery

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

  • Procedure: VALA

    Procedure/Surgery

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

Treatment groups

184 Participants
are divided into 2 treatment groups
Group A: Radial 2ring fiberActive comparator 1 intervention
Group B: Radial 2ring Pro fiberActive comparator 1 intervention

Trial outcomes

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

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

Secondary outcomes

1

Pain score and use of painkillers

A questionnaire including the Numeric Rating Scale (NRS) of pain is filled in by the patient. It is a numeric scale from 0 (no pain) to 10 (worst imaginable pain).

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

Clinical status

CEAP classification. The CEAP classification is a common descriptive platform for the reporting of diagnostic information in chronic venous disease, as well as a tool for regular patient documentation and management. The clinical component indicates disease severity, ranging from none (0 points) to active ulcers (6 points). The etiologic component denotes the venous disease as congenital, primary, or secondary in nature. The anatomic classification pinpoints the veins involved as superficial, deep, or perforating. The pathophysiologic classification identifies the presence of reflux in the superficial,communicating, or deep systems, as well as the existence of outflow obstruction.

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

Severity of chronic venous diseases

Venous Clinical Severity Score (VCSS). The VCSS includes 9 hallmarks of venous disease, each scored on a severity scale from 0 to 3.

Time frame
2 weeks, one month, 3 months and 6 months post treatment
4

Health related quality of life

A questionnaire Chronic Venous Insufficiency Questionnaire (CIVIQ 20) is filled in by the patient. The CIVIQ comprises 20 questions in four quality-of-life domains: physical, psychological, social, and pain.The result ranges from 0 to 100.

Time frame
one month, 3 months and 6 months post treatment

Other outcomes

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Center Of PhlebologyRecruiting720023, Bishkek, Chuy RegionKyrgyzstanKyrgyzstan

Sponsors and contacts

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Center Of Phlebology

Lead sponsor

Source ClinicalTrials.gov
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