Actively Recruiting
Vacuum-assisted Laser Ablation (VALA) for Treatment of Large Saphenous Veins
Led by Center Of Phlebology · Updated on 2025-05-14
184
Participants Needed
9
Research Sites
48 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Vacuum-assisted Laser Ablation (VALA) for Treatment of Large Saphenous Veins
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age over 18 years
- Varicose veins of the lower extremities with clinical class C2-C6
- Diameter of the great saphenous vein or small saphenous vein 15 mm or larger in standing position
- Provided informed consent to participate
You will not qualify if you...
- Pregnancy or breastfeeding
- Malignant tumors
- Unable or unwilling to wear compression stockings
- Allergy to lidocaine
- Diabetes mellitus
- Bronchial asthma
- Severe liver or kidney disease
- Acute thrombosis or thrombophlebitis
- Skin or soft tissue infection
- Infectious diseases
- Peripheral arteriosclerosis
- Diabetic angiopathy
- Heart defects requiring surgery
- Fever
- Toxic hyperthyroidism
- Obesity
- Tuberculosis
- Sepsis
- Blood cell disorders
- Conditions requiring bed rest
- Heart failure with decompensation
- Known hereditary thrombophilia
- Recent 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
AI-Screening
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Trial Site Locations
Total: 9 locations
1
Clinic in Uruchye
Minsk, Belarus
Actively Recruiting
2
Merci clinic
Minsk, Belarus
Actively Recruiting
3
SANTE clinic
Minsk, Belarus
Actively Recruiting
4
Center Of Phlebology
Bishkek, Chuy Region, Kyrgyzstan, 720023
Actively Recruiting
5
Laser Surgery Center
Moscow, Russia
Actively Recruiting
6
Innovative vascular centre
Saint Petersburg, Russia
Actively Recruiting
7
Derzhavin Tambov State University
Tambov, Russia, 392002
Actively Recruiting
8
Clinic of Modern Phlebology "VarikozOFF"
Tashkent, Uzbekistan
Actively Recruiting
9
Clinic of Modern Phlebology "VarikozOFF"
Tashkent, Uzbekistan
Actively Recruiting
Research Team
D
Dmitrii N Alekseev, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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