Varicose VeinsNCT06971068
Vacuum-assisted Laser Ablation (VALA) for Treatment of Large Saphenous Veins
A study testing Procedure: EVLA and Procedure: VALA in people with Varicose Veins, run by Center Of Phlebology at 9 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Varicose Veins
- What is being tested?
- Procedure: EVLA and Procedure: VALA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 184 participants
- Where
- 9 sitesin 4 countries
- Study dates
- 15 Mar 2025to 15 Feb 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
9 sites in 4 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 4 countries
Belarus3 sites, 3 recruiting
- Recruiting
Clinic in Uruchye
Minsk
Siarhei Karniyevich, +375296296006, skarniyevich@gmail.com
- Recruiting
Merci clinic
Minsk
Olga Pozniakova, +375447900263, opozniakova@gmail.com
- Recruiting
SANTE clinic
Minsk
Pavel Hauryn, +375296661304, pgavrin@gmail.com
Russia3 sites, 3 recruiting
- Recruiting
Laser Surgery Center
Moscow
Evgeny Letunovsky, PhD, +79265247293, flebolog@bk.ru
- Recruiting
Innovative vascular centre
Saint Petersburg
Matvey Parikov, +79062717394, parikow@mail.ru
- Recruiting
Derzhavin Tambov State University
Tambov, 392002
Oksana V Bukina, PhD, +79051204983, ovsafonova@yandex.ru
Uzbekistan2 sites, 2 recruiting
- Recruiting
Clinic of Modern Phlebology "VarikozOFF"
Tashkent
Akmal Norkulov, +998909434485, norkulovakmal@gmail.com
- Recruiting
Clinic of Modern Phlebology "VarikozOFF"
Tashkent
Farhad Umarov, PhD, +998977510863, professoruf83@mail.ru
Kyrgyzstan1 site, 1 recruiting
- Recruiting
Center Of Phlebology
Bishkek, Chuy Region, 720023
Dmitrii N Alekseev, PhD, +996555521274, dm.alekseev81@gmail.com
About this study
Official title: Endovenous Vacuum-assisted Laser Ablation (VALA) in the Treatment of Large Saphenous Veins (> 15 mm)
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).
Read the detailed description
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:
- great saphenous vein: saphenofemoral junction (SFJ), vein ectasia below the SFJ by 3 cm, upper third of the thigh, middle third of the thigh, lower third of the thigh, upper third of the leg, middle third of the leg, lower third of the leg;
- small saphenous vein: saphenopopliteal junction (SPJ), ectasia below the SPJ by 3 cm, upper third of the leg, middle third of the leg, lower third of the leg.
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).
- Conditions
- Varicose Veins
- Being tested
- Procedure: EVLA, Procedure: VALA
- Keywords
- Vacuum-assisted Laser Ablation, large saphenous veins, varicose veins, EVLA
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure: EVLAProcedure or surgery
Great or small saphenous vein occlusion with endovenous laser ablation using ELVeS Radial 2ring fiber
Procedure: VALAProcedure or surgery
Great or small saphenous vein occlusion with endovenous laser ablation using ELVeS Radial 2ring Pro fiber
| Study group | Role | What they receive |
|---|---|---|
| Radial 2ring fiber | Active comparator | Refluxing GSV/SSV treated with endovenous laser ablation using ELVeS Radial 2ring fiber Receives: Procedure: Procedure: EVLA |
| Radial 2ring Pro fiber | Active comparator | Refluxing GSV/SSV treated with endovenous laser ablation using ELVeS Radial 2ring Pro fiber Receives: Procedure: Procedure: VALA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occlusion of the treated GSV/SSV
Obliteration of varicose vein along the treated segment of the GSV/SSV measured using ultrasound (US) examination
Measured: One day, 2 weeks, one month, 3 months and 6 months post treatment
Secondary outcomes (7)
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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
Measured: 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
Measured: 2 weeks, one month, 3 months and 6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2025
- Study start15 Mar 2025
- Primary completion15 Sep 2025 (estimated)
- Study completion15 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Varicose VeinsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 184 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center Of Phlebology
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Dmitrii Alekseev, Center Of Phlebology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06971068
- Sponsor's protocol ID
- CenterPhlebology
- Status last verified
- May 2025
- First submitted
- 2 May 2025
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study data are available to all investigators in the chronic vein disease registry
Publications
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.
PubMed 26994834Sufian 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.
PubMed 24609619Bontinis 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.
PubMed 37458188Elboushi 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.
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.
PubMed 28956693
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endovenous Vacuum-assisted Laser Ablation (VALA) in the Treatment of Large Saphenous Veins (> 15 mm)
- ClinicalTrials.gov ID
- NCT06971068
- Acronym / sponsor ID
- CenterPhlebology
- Conditions
- Varicose Veins
- Keywords
- Vacuum-assisted Laser Ablation, large saphenous veins, varicose veins, EVLA
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 184 participants (estimated)
- Lead sponsor
- Center Of PhlebologyResearch network
- Study start
- 15 Mar 2025 (actual)
- Primary completion
- 15 Sep 2025 (estimated)
- Study completion
- 15 Feb 2026 (estimated)
- First posted
- 14 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Detailed description
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:
- great saphenous vein: saphenofemoral junction (SFJ), vein ectasia below the SFJ by 3 cm, upper third of the thigh, middle third of the thigh, lower third of the thigh, upper third of the leg, middle third of the leg, lower third of the leg;
- small saphenous vein: saphenopopliteal junction (SPJ), ectasia below the SPJ by 3 cm, upper third of the leg, middle third of the leg, lower third of the leg.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Radial 2ring fiber | Active comparator | Procedure: Procedure: EVLARefluxing GSV/SSV treated with endovenous laser ablation using ELVeS Radial 2ring fiber |
| Radial 2ring Pro fiber | Active comparator | Procedure: Procedure: VALARefluxing GSV/SSV treated with endovenous laser ablation using ELVeS Radial 2ring Pro fiber |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Procedure: EVLAGreat or small saphenous vein occlusion with endovenous laser ablation using ELVeS Radial 2ring fiber | Procedure or surgery | Radial 2ring fiber |
| Procedure: VALAGreat or small saphenous vein occlusion with endovenous laser ablation using ELVeS Radial 2ring Pro fiber | Procedure or surgery | Radial 2ring Pro fiber |
Primary outcome
Occlusion of the treated GSV/SSV
Time frame: One day, 2 weeks, one month, 3 months and 6 months post treatment
Obliteration of varicose vein along the treated segment of the GSV/SSV measured using ultrasound (US) examination
7 secondary outcomes
Pain score and use of painkillers
Time frame: One day, 2 weeks, one month, 3 months and 6 months post treatment
Clinical status
Time frame: 2 weeks, one month, 3 months and 6 months post treatment
Severity of chronic venous diseases
Time frame: 2 weeks, one month, 3 months and 6 months post treatment
Health related quality of life
Time frame: one month, 3 months and 6 months post treatment
Histological picture of the treated vein
Time frame: 2 weeks, one month, 3 months post treatment
Number of patients with adverse events
Time frame: One day, 2 weeks, one month, 3 months and 6 months post treatment
Severity of hyperpigmentation
Time frame: 2 weeks, one month, 3 months and 6 months post treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Background: PubMed 26994834Van 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.
- Background: PubMed 24609619Sufian 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.
- Background: PubMed 37458188Bontinis 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.
- BackgroundElboushi 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: PubMed 28956693Dabbs 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.
- Individual participant dataSharing planned: Yes. The study data are available to all investigators in the chronic vein disease registry
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
9 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedure: EVLA and Procedure: VALA in people with Varicose Veins, run by Center Of Phlebology at 9 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Belarus, Russia, Uzbekistan, Kyrgyzstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dmitrii N Alekseev, PhD (+996555521274, dm.alekseev81@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occlusion of the treated GSV/SSV (time frame: One day, 2 weeks, one month, 3 months and 6 months post treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06971068, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.