An interventional study of Procedure: EVLA and Procedure: VALA in Varicose Veins, sponsored by Center Of Phlebology. Recruiting at 9 sites in 4 countries. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2025-05-14.
Sponsored by Center Of Phlebology · Not applicable, Interventional, and Treatment
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).
Preoperatively all patients should be examined in a standing position clinically and with duplex ultrasound (DUS) marking of the diameters of the target great saphenous veins (GSV) or small saphenous veins (SSV) at the following levels:
It is recommended to calculate the required linear energy density (LEED) per centimeter of vein length using the following formula depending on the level of measurement of the target vein diameter: LEED=d*k, where LEED is the linear energy density (J/cm), "d" is the vein diameter (mm), "k" is the coefficient based on the measurement level: upper half of the thigh - 10, lower half of the thigh - 8, upper half of the leg - 6, lower half of the leg - 4.
Under local anesthesia, the target vein is punctured and the introducer is then installed. For the first group of patients (ELVeS Radial 2ring fiber), there is no need for preliminary preparation of the fiber. For the second group (ELVeS Radial 2ring Pro fiber), it is recommended to fill the ELVes Radial 2ring Pro catheter with a pre-prepared heparin solution (200 ml 0.9% Na Cl + 1 ml (5000) heparin) before use. Passing the fiber and installing it in the orifice of the target vein. Performing tumescent anesthesia (1000 ml 0.9% NaCl, 10 ml 2% lidocaine, 0.25 ml 0.1% adrenaline, 56 ml 4% sodium bicarbonate at room temperature) with recording the volume of the solution used. Performing EVLA with recording the parameters at different levels (power, extraction rate). When performing laser obliteration in patients of the second group, the ELVeS Radial 2ring Pro fiber catheter is connected to a vacuum suction using a high-pressure line to evacuate residual blood from the lumen of the vein during EVLA. Compression underwear of class 2 according to RAL or class 3 according to ASQUAL (23-32 mm Hg).
226 studies on the registry are indexed under Varicose Veins; 30 are open to participants now.
This study's planned enrollment of 184 is above the median of 101 across 154 interventional studies indexed under Varicose Veins.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Refluxing GSV/SSV treated with endovenous laser ablation using ELVeS Radial 2ring fiber
Procedure: Procedure: EVLA
Refluxing GSV/SSV treated with endovenous laser ablation using ELVeS Radial 2ring Pro fiber
Procedure: Procedure: VALA
Great or small saphenous vein occlusion with endovenous laser ablation using ELVeS Radial 2ring fiber
Great or small saphenous vein occlusion with endovenous laser ablation using ELVeS Radial 2ring Pro fiber
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
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
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
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
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
Histological picture of the treated vein
A time period of connective tissue transformation of the vein wall and its lysis assessed by histochemical analysis (Picro-Mallory, Martius-Scarlet-Blue, Fuchsin-Miller)
Time frame: 2 weeks, one month, 3 months post treatment
Number of patients with adverse events
Major complications: superficial and deep venous thrombosis including EHIT, nerve injury, skin burns, and subcutaneous infections. Minor complications: ecchymosis and hyperpigmentation
Time frame: One day, 2 weeks, one month, 3 months and 6 months post treatment
Severity of hyperpigmentation
Skin tone estimated using the Pantone SkinTone Guide and compared with an unchanged area of skin
Time frame: 2 weeks, one month, 3 months and 6 months post treatment
Plan to share: Yes — The study data are available to all investigators in the chronic vein disease registry
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: From 15 March 2025 to 15 February 2026
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