Varicose VeinsPRETANCT04034329
PREservation Versus Thermal Ablation
An observational study of Varicose Veins, run by Belarusian State Medical University at 1 site in Belarus.
Trial summary
This study will be looking at the effect of Ambulatory Selective Varices Ablation under Local Anesthesia (ASVAL) and Endovenous Laser Ablation (EVLA) with concomitant phlebectomy in patients with incompetent great saphenous vein (GSV). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Varicose Veins
- What is being tested?
- ASVAL and EVLA
- Type of treatment
- Surgery or procedure
- How many people
- 300 participants
- Where
- 1 siteBelarus
- Study dates
- 1 Jan 2013to 1 Feb 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with GSV incompetence and C2-C3 were included in the prospective consecutive case study if they satisfied the selection criteria
Who may be able to join
- Great saphenous vein (GSV) incompetence with reflux at least down to the knee level
- Primary symptomatic varicose veins, Clinical Etiological Anatomical Pathophysiological (CEAP) classification, clinical class C2-C3
- Physical status according to American Society of Anesthesiologists (ASA) I-II (I-Healthy, non-smoking, no or minimal alcohol use; II-Mild diseases only without substantive functional limitations)
Who cannot join
- Previous surgical groin exploration, except herniotomy
- Small saphenous vein, anterior or posterior accessory saphenous vein incompetence at the same limb
- Deep venous thrombosis, thrombophilia associated with a high risk of deep venous thrombosis or postthrombotic syndrome
- Arterial occlusive disease more severe than Intermittent claudication after more than 200 meters of pain free walking (Fontaine IIA) and/or ankle brachial index below 0.8
Trial locations and contacts
1 site in 1 country.
Belarus1 site
Educational Institution"Belarusian State Medical University"
Minsk, Dzerzhinski Ave., 83, 220116
About this study
Official title: PREservation Versus Thermal Ablation of the Incompetent Great Saphenous Vein in Varicose Veins Treatment
This study will be looking at the effect of Ambulatory Selective Varices Ablation under Local Anesthesia (ASVAL) and Endovenous Laser Ablation (EVLA) with concomitant phlebectomy in patients with incompetent great saphenous vein (GSV).
Read the detailed description
Full venous duplex ultrasonography was performed using Medical ultrasound scan. Cognizant of the negative consequences of standing and sitting for long periods of time (e.g. venous hypertension, venous reflux), we scheduled investigations for early morning, thus ensuring examination of the physiological status of the venous system in each patient. Ultrasound examinations of reflux at the saphenofemoral junction (SFJ) were performed using the Valsalva maneuver. Ultrasound examination of GSV reflux was performed by manually compressing the calf followed by sudden release. Reverse flow that lasted more than 0.5 seconds was considered pathological. Preoperative venous duplex mapping was done in the upright position. Further measurements of the GSV diameter 15 cm below the SFJ level were conducted to describe the severity of varicose veins more accurately.
The diameter of GSV at the 15-cm below the SFJ level was the main criterion to identify two groups of patients. Those with the GSV diameter ≤ 6 mm were treated with ASVAL. If the diameter of GSV was > 6 mm, EVLA with concomitant phlebectomy was performed.
All surgical procedures were accomplished by the same surgeon, using tumescent local anesthesia (i.e. 0,1% lidocaine and sodium bicarbonate solution without epinephrine).The EVLA was done under duplex guidance with a 1560-nm diode laser using bare fibres via a Seldinger wire technique. The GSV was cannulated at the lowest point of the reflux. The laser fiber was advanced below the SFJ at the level of v. epigastrica sup. after which the GSV was ablated during gradual withdrawal of the fibre. The 15 Watts laser power was delivered in a continuous pull back traction. The average applied linear endovenous energy dose (LEED) was 75,3 J/cm.
Peripheral side branches were removed by multiple stab avulsions in both groups. After the treatment, the leg was wrapped in sterile absorbent bandages, and compression stockings class II (23-32 mm Hg) were put on and recommended to wear for two weeks. All patients were discharged on the day of the treatment and were invited to a follow-up duplex ultrasonography (DUS) on the 1st post-operative day, 2 years and 5 years after the operation (patients were contacted by phone). DUS at follow-up visits was carried out by an independent specialist who was not involved in the initial treatment of the patients. To report clinical recurrence after EVLA we have used Group d' Evaluation des Lasers et de l'Echographie Vasculare (GELEV) score.
- Conditions
- Varicose Veins
- Being tested
- ASVAL, EVLA
- Keywords
- ASVAL, EVLA, GSV, Long-term efficacy
- Medical subject headings
- Varicose Veins
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ASVALProcedure or surgery
Ambulatory Selective Varices Ablation under Local Anesthesia
EVLAProcedure or surgery
Endovenous Laser Ablation
| Study group | Role | What they receive |
|---|---|---|
| ASVAL - group | GSV diameter ≤ 6 mm Receives: Procedure: ASVAL | |
| EVLA-group | GSV diameter > 6 mm Receives: Procedure: EVLA |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with pain or other discomfort (ie aching, heaviness, fatigue, soreness, burning) from absent (score 0) to severe (score 3)
None (0), Occasional (1), Daily, interfering with, but not preventing regular daily activities (2), Daily limiting most regular daily activities (3)
Measured: 5-10 years
Number of Participants with varicose Veins from absent (score 0) to severe (score 3).
None (0), Few, scattered (1), Confined to calf or thigh (2) Involve calf and thigh (3)
Measured: 5-10 years
Number of Participants with venous oedema from absent (score 0) to severe (score 3).
None (0) Limited to foot or ankle (1), Extends above ankle but below knee (2), Extends to knee or above (3)
Measured: 5-10 years
Number of Participants with skin Pigmentation from absent (score 0) to severe (score 3).
None (0), Limited to perimalleolar area (1), Diffuse over lower third of calf (2), Wider distribution (above lower third of calf) (3)
Measured: 5-10 years
Number of Participants with inflammation from absent (score 0) to severe (score 3).
None (0), Limited to perimalleolar area (1), Diffuse over lower third of calf (2), Wider distribution (above lower third of calf) (3)
Measured: 5-10 years
Number of Participants with zone of induration from absent (score 0) to severe (score 3).
None (0), Limited to perimalleolar area (1), Involving lower third of calf (2), Involving more than lower third of calf (3)
Measured: 5-10 years
Number of Participants with number of active ulcers from absent (score 0) to severe (score 3).
None (0), 1 (1), 2 (2), more than 2 (3)
Measured: 5-10 years
Number of Participants with different duration of active ulcer: from absent (score 0) to severe (score 3).
None (0), Less than 3 months (1), More than 3 months but less than 1 year (2) More than 1year (3)
Measured: 5-10 years
Number of Participants with active ulcer diameter from absent (score 0) to severe (score 3).
None (0), Diameter less than 2 cm (1), Diameter 2-6 cm (2), Diameter more than 6 cm (3)
Measured: 5-10 years
Number of Participants with compression therapy from absent (score 0) to severe (score 3).
Not used (0), Intermittent use of stockings (1), Uses stockings most days (2), Full compliance with stockings (3)
Measured: 5-10 years
Secondary outcomes (1)
Number of Participants with clinical recurrence-free rate (no - score 0, yes - score 1)
Visible or palpable varicosity with a diameter of less than 3 mm after surgery (0). Visible or palpable varicosity with a diameter of more than 3 mm after surgery (1).
Measured: 5-10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start1 Jan 2013
- Primary completion23 Jul 2025
- Study completion1 Feb 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Belarusian State Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ihar Ihnatovich, Belarusian State Medical University
- Investigators
- Genadz Kandratsenka, Prof, Study chair, Educational Institution"Belarusian State Medical University"
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04034329
- Sponsor's protocol ID
- 20140451
- Acronym
- PRETA
- Status last verified
- Oct 2026
- First submitted
- 23 Jul 2019
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: To compare clinical efficacy of Ambulatory Selective Varices Ablation under Local Anesthesia (ASVAL) and Endovenous Laser Ablation (EVLA) with concomitant phlebectomy in patients with incompetent great saphenous vein (GSV).
Publications
Pittaluga P, Chastanet S. Persistent incompetent truncal veins should not be treated immediately. Phlebology. 2015 Mar;30(1 Suppl):98-106. doi: 10.1177/0268355515569141.
PubMed 25729076Chastanet S, Pittaluga P. Influence of the competence of the sapheno-femoral junction on the mode of treatment of varicose veins by surgery. Phlebology. 2014 May;29(1 suppl):61-65. doi: 10.1177/0268355514529207. Epub 2014 May 19.
PubMed 24843088van Neer P, Kessels FG, Estourgie RJ, de Haan EF, Neumann MA, Veraart JC. Persistent reflux below the knee after stripping of the great saphenous vein. J Vasc Surg. 2009 Oct;50(4):831-4. doi: 10.1016/j.jvs.2009.05.021. Epub 2009 Jul 12.
PubMed 19595549Zolotukhin IA, Seliverstov EI, Zakharova EA, Kirienko AI. Short-term results of isolated phlebectomy with preservation of incompetent great saphenous vein (ASVAL procedure) in primary varicose veins disease. Phlebology. 2017 Oct;32(9):601-607. doi: 10.1177/0268355516674415. Epub 2016 Oct 19.
PubMed 27760806Harlander-Locke M, Jimenez JC, Lawrence PF, Derubertis BG, Rigberg DA, Gelabert HA. Endovenous ablation with concomitant phlebectomy is a safe and effective method of treatment for symptomatic patients with axial reflux and large incompetent tributaries. J Vasc Surg. 2013 Jul;58(1):166-72. doi: 10.1016/j.jvs.2012.12.054. Epub 2013 Apr 6.
PubMed 23571079Puggioni A, Kalra M, Carmo M, Mozes G, Gloviczki P. Endovenous laser therapy and radiofrequency ablation of the great saphenous vein: analysis of early efficacy and complications. J Vasc Surg. 2005 Sep;42(3):488-93. doi: 10.1016/j.jvs.2005.05.014.
PubMed 16171593Nesbitt C, Bedenis R, Bhattacharya V, Stansby G. Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus open surgery for great saphenous vein varices. Cochrane Database Syst Rev. 2014 Jul 30;(7):CD005624. doi: 10.1002/14651858.CD005624.pub3.
PubMed 25075589
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PREservation Versus Thermal Ablation of the Incompetent Great Saphenous Vein in Varicose Veins Treatment
- ClinicalTrials.gov ID
- NCT04034329
- Acronym / sponsor ID
- PRETA / 20140451
- Conditions
- Varicose Veins
- Keywords
- ASVAL, EVLA, GSV, Long-term efficacy
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Belarusian State Medical UniversityUniversity, hospital or other
- Study start
- 1 Jan 2013 (actual)
- Primary completion
- 23 Jul 2025 (actual)
- Study completion
- 1 Feb 2030 (estimated)
- First posted
- 26 Jul 2019 (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.
This study will be looking at the effect of Ambulatory Selective Varices Ablation under Local Anesthesia (ASVAL) and Endovenous Laser Ablation (EVLA) with concomitant phlebectomy in patients with incompetent great saphenous vein (GSV).
Detailed description
Full venous duplex ultrasonography was performed using Medical ultrasound scan. Cognizant of the negative consequences of standing and sitting for long periods of time (e.g. venous hypertension, venous reflux), we scheduled investigations for early morning, thus ensuring examination of the physiological status of the venous system in each patient. Ultrasound examinations of reflux at the saphenofemoral junction (SFJ) were performed using the Valsalva maneuver. Ultrasound examination of GSV reflux was performed by manually compressing the calf followed by sudden release. Reverse flow that lasted more than 0.5 seconds was considered pathological. Preoperative venous duplex mapping was done in the upright position. Further measurements of the GSV diameter 15 cm below the SFJ level were conducted to describe the severity of varicose veins more accurately.
The diameter of GSV at the 15-cm below the SFJ level was the main criterion to identify two groups of patients. Those with the GSV diameter ≤ 6 mm were treated with ASVAL. If the diameter of GSV was > 6 mm, EVLA with concomitant phlebectomy was performed.
All surgical procedures were accomplished by the same surgeon, using tumescent local anesthesia (i.e. 0,1% lidocaine and sodium bicarbonate solution without epinephrine).The EVLA was done under duplex guidance with a 1560-nm diode laser using bare fibres via a Seldinger wire technique. The GSV was cannulated at the lowest point of the reflux. The laser fiber was advanced below the SFJ at the level of v. epigastrica sup. after which the GSV was ablated during gradual withdrawal of the fibre. The 15 Watts laser power was delivered in a continuous pull back traction. The average applied linear endovenous energy dose (LEED) was 75,3 J/cm.
Peripheral side branches were removed by multiple stab avulsions in both groups. After the treatment, the leg was wrapped in sterile absorbent bandages, and compression stockings class II (23-32 mm Hg) were put on and recommended to wear for two weeks. All patients were discharged on the day of the treatment and were invited to a follow-up duplex ultrasonography (DUS) on the 1st post-operative day, 2 years and 5 years after the operation (patients were contacted by phone). DUS at follow-up visits was carried out by an independent specialist who was not involved in the initial treatment of the patients. To report clinical recurrence after EVLA we have used Group d' Evaluation des Lasers et de l'Echographie Vasculare (GELEV) score.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ASVAL - group | – | Procedure: ASVALGSV diameter ≤ 6 mm |
| EVLA-group | – | Procedure: EVLAGSV diameter > 6 mm |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with GSV incompetence and C2-C3 were included in the prospective consecutive case study if they satisfied the selection criteria
Key inclusion criteria (3 listed)
- Great saphenous vein (GSV) incompetence with reflux at least down to the knee level
- Primary symptomatic varicose veins, Clinical Etiological Anatomical Pathophysiological (CEAP) classification, clinical class C2-C3
- Physical status according to American Society of Anesthesiologists (ASA) I-II (I-Healthy, non-smoking, no or minimal alcohol use; II-Mild diseases only without substantive functional limitations)
Key exclusion criteria (4 listed)
- Previous surgical groin exploration, except herniotomy
- Small saphenous vein, anterior or posterior accessory saphenous vein incompetence at the same limb
- Deep venous thrombosis, thrombophilia associated with a high risk of deep venous thrombosis or postthrombotic syndrome
- Arterial occlusive disease more severe than Intermittent claudication after more than 200 meters of pain free walking (Fontaine IIA) and/or ankle brachial index below 0.8
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 |
|---|---|---|
| ASVALAmbulatory Selective Varices Ablation under Local Anesthesia | Procedure or surgery | ASVAL - group |
| EVLAEndovenous Laser Ablation | Procedure or surgery | EVLA-group |
Primary outcome
Number of Participants with pain or other discomfort (ie aching, heaviness, fatigue, soreness, burning) from absent (score 0) to severe (score 3)
Time frame: 5-10 years
None (0), Occasional (1), Daily, interfering with, but not preventing regular daily activities (2), Daily limiting most regular daily activities (3)
Number of Participants with varicose Veins from absent (score 0) to severe (score 3).
Time frame: 5-10 years
None (0), Few, scattered (1), Confined to calf or thigh (2) Involve calf and thigh (3)
Number of Participants with venous oedema from absent (score 0) to severe (score 3).
Time frame: 5-10 years
None (0) Limited to foot or ankle (1), Extends above ankle but below knee (2), Extends to knee or above (3)
Number of Participants with skin Pigmentation from absent (score 0) to severe (score 3).
Time frame: 5-10 years
None (0), Limited to perimalleolar area (1), Diffuse over lower third of calf (2), Wider distribution (above lower third of calf) (3)
Number of Participants with inflammation from absent (score 0) to severe (score 3).
Time frame: 5-10 years
None (0), Limited to perimalleolar area (1), Diffuse over lower third of calf (2), Wider distribution (above lower third of calf) (3)
Number of Participants with zone of induration from absent (score 0) to severe (score 3).
Time frame: 5-10 years
None (0), Limited to perimalleolar area (1), Involving lower third of calf (2), Involving more than lower third of calf (3)
Number of Participants with number of active ulcers from absent (score 0) to severe (score 3).
Time frame: 5-10 years
None (0), 1 (1), 2 (2), more than 2 (3)
Number of Participants with different duration of active ulcer: from absent (score 0) to severe (score 3).
Time frame: 5-10 years
None (0), Less than 3 months (1), More than 3 months but less than 1 year (2) More than 1year (3)
Number of Participants with active ulcer diameter from absent (score 0) to severe (score 3).
Time frame: 5-10 years
None (0), Diameter less than 2 cm (1), Diameter 2-6 cm (2), Diameter more than 6 cm (3)
Number of Participants with compression therapy from absent (score 0) to severe (score 3).
Time frame: 5-10 years
Not used (0), Intermittent use of stockings (1), Uses stockings most days (2), Full compliance with stockings (3)
1 secondary outcome
Number of Participants with clinical recurrence-free rate (no - score 0, yes - score 1)
Time frame: 5-10 years
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 5 Oct 2026.
- Background: PubMed 25729076Pittaluga P, Chastanet S. Persistent incompetent truncal veins should not be treated immediately. Phlebology. 2015 Mar;30(1 Suppl):98-106. doi: 10.1177/0268355515569141.
- Background: PubMed 24843088Chastanet S, Pittaluga P. Influence of the competence of the sapheno-femoral junction on the mode of treatment of varicose veins by surgery. Phlebology. 2014 May;29(1 suppl):61-65. doi: 10.1177/0268355514529207. Epub 2014 May 19.
- Background: PubMed 19595549van Neer P, Kessels FG, Estourgie RJ, de Haan EF, Neumann MA, Veraart JC. Persistent reflux below the knee after stripping of the great saphenous vein. J Vasc Surg. 2009 Oct;50(4):831-4. doi: 10.1016/j.jvs.2009.05.021. Epub 2009 Jul 12.
- Background: PubMed 27760806Zolotukhin IA, Seliverstov EI, Zakharova EA, Kirienko AI. Short-term results of isolated phlebectomy with preservation of incompetent great saphenous vein (ASVAL procedure) in primary varicose veins disease. Phlebology. 2017 Oct;32(9):601-607. doi: 10.1177/0268355516674415. Epub 2016 Oct 19.
- Background: PubMed 23571079Harlander-Locke M, Jimenez JC, Lawrence PF, Derubertis BG, Rigberg DA, Gelabert HA. Endovenous ablation with concomitant phlebectomy is a safe and effective method of treatment for symptomatic patients with axial reflux and large incompetent tributaries. J Vasc Surg. 2013 Jul;58(1):166-72. doi: 10.1016/j.jvs.2012.12.054. Epub 2013 Apr 6.
- Background: PubMed 16171593Puggioni A, Kalra M, Carmo M, Mozes G, Gloviczki P. Endovenous laser therapy and radiofrequency ablation of the great saphenous vein: analysis of early efficacy and complications. J Vasc Surg. 2005 Sep;42(3):488-93. doi: 10.1016/j.jvs.2005.05.014.
- Background: PubMed 25075589Nesbitt C, Bedenis R, Bhattacharya V, Stansby G. Endovenous ablation (radiofrequency and laser) and foam sclerotherapy versus open surgery for great saphenous vein varices. Cochrane Database Syst Rev. 2014 Jul 30;(7):CD005624. doi: 10.1002/14651858.CD005624.pub3.
- Individual participant dataSharing planned: Yes. To compare clinical efficacy of Ambulatory Selective Varices Ablation under Local Anesthesia (ASVAL) and Endovenous Laser Ablation (EVLA) with concomitant phlebectomy in patients with incompetent great saphenous vein (GSV).
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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. This study is not recruiting at the moment.
Genadz Kandratsenka, Prof study chair
Educational Institution"Belarusian State Medical University"
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Varicose Veins, run by Belarusian State Medical University at 1 site in Belarus.
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 4 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: under way, not looking for participants, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belarus. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with pain or other discomfort (ie aching, heaviness, fatigue, soreness, burning) from absent (score 0) to severe (score 3) (time frame: 5-10 years). The study lists 10 primary outcomes in all. 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 NCT04034329, which also lists 7 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 5 Oct 2026.