Endovenous Vacuum-assisted Laser Ablation (VALA) in the Treatment of Large Saphenous Veins (> 15 mm)

Status: Recruiting
Location: See all (9) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 90
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Belarus
Clinic in Uruchye
RECRUITING
Minsk
Merci clinic
RECRUITING
Minsk
SANTE clinic
RECRUITING
Minsk
Kyrgyzstan
Center Of Phlebology
RECRUITING
Bishkek
Russian Federation
Laser Surgery Center
RECRUITING
Moscow
Innovative vascular centre
RECRUITING
Saint Petersburg
Derzhavin Tambov State University
RECRUITING
Tambov
Uzbekistan
Clinic of Modern Phlebology VarikozOFF
RECRUITING
Tashkent
Clinic of Modern Phlebology VarikozOFF
RECRUITING
Tashkent
Contact Information
Primary
Dmitrii N Alekseev, PhD
dm.alekseev81@gmail.com
+996555521274
Time Frame
Start Date: 2025-03-15
Estimated Completion Date: 2026-02-15
Participants
Target number of participants: 184
Treatments
Active_comparator: Radial 2ring fiber
Refluxing GSV/SSV treated with endovenous laser ablation using ELVeS Radial 2ring fiber
Active_comparator: Radial 2ring Pro fiber
Refluxing GSV/SSV treated with endovenous laser ablation using ELVeS Radial 2ring Pro fiber
Related Therapeutic Areas
Sponsors
Leads: Center Of Phlebology

This content was sourced from clinicaltrials.gov