Varicose VeinsLACROSS-VVPNCT07449728
The Influence of Laser Crossectomy With Different Wavelengths on Varicose Vein Progression
A study testing Laser crossectomy on 1470 nm, Laser crossectomy on 1940 nm and Standard EVLT with a stump in people with Varicose Veins and Chronic Venous Insufficiency, run by Pirogov Russian National Research Medical University at 1 site in Russia.
Trial summary
Technically successful laser crossectomy will reduce the risk of reflux recurrence at the sapheno-femoral junction without increasing the risk of endovenous heat-induced thrombosis, which may positively impact the likelihood of ultrasound- or clinical-recurrence of varicose veins. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Varicose Veins, Chronic Venous Insufficiency
- What is being tested?
- Laser crossectomy on 1470 nm, Laser crossectomy on 1940 nm and Standard EVLT with a stump
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteRussia
- Study dates
- 20 Jan 2026to 20 Jan 2029
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Primary VVs of Clinical Etiology Anatomy Pathophysiology (CEAP) clinical class of C2-C6
- Reflux along the GSV trunk lasting >0.5 sec.
- GSV trunk diameter ≤12 mm
- Informed consent to participate in the study
Who cannot join
- Primary reflux outside the GSV trunk (including combined reflux)
- History of deep or superficial vein thrombosis
- Deep vein reflux
- Non-thrombotic or post-thrombotic venous obstruction
- Pelvic venous insufficiency
- Use of oral anticoagulants
Show all 9Show fewer
- Indication for pharmacological prophylaxis after EVLT
- Inability to use radial fiber of 1.4-1.57 mm at the surgeon's discretion
- Refusal to participate in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Russia1 site, 1 recruiting
- Recruiting
MedSwiss Private Cinic
Moscow, 143082
Kirill Lobastov, PhD, +7-985-211-63-31, lobastov_kv@hotmail.com
About this study
Technically successful laser crossectomy will reduce the risk of reflux recurrence at the sapheno-femoral junction without increasing the risk of endovenous heat-induced thrombosis, which may positively impact the likelihood of ultrasound- or clinical-recurrence of varicose veins. Similar technical efficacy is expected for laser crossectomy at 1940 nm and 1470 nm. A possible advantage of the 1940 nm wavelength in terms of postoperative pain intensity and the risk of adverse events cannot be ruled out.
Read the detailed description
Chronic venous disorder (CVD), including primary varicose veins (VV) of the lower limbs and progressive forms with chronic venous insufficiency (CVI), is an important medical and social problem due to its high prevalence in the population and its significant burden on healthcare systems. According to general data, up to 19% of the population has primary varicose veins, and up to 13.5% has signs of CVI. At present, the main approach to surgical treatment of VVs is the elimination of pathological reflux, for which minimally invasive endovascular techniques are recommended. The latter, including endovascular laser treatment (EVLT), is noninferior to open surgery in technical efficiency but is associated with a lower risk of postoperative complications. Among all adverse events after EVLT, the most important one is venous thromboembolism (VTE), including endovenous heat-induced thrombosis (EHIT). The incidence of EHIT may depend on the position of the laser fiber relative to the sapheno-femoral junction (SFJ).
Recurrent varicose veins, occurring in 10-62% of patients, are the leading consequence of varicose vein surgery in long-term follow-up. The causes of recurrence depend on the type of primary intervention, with recanalization and reflux recurrence at the SFJ after EVLT being the most common.
In order to reduce the risk of varicose veins recurrence, it was proposed to perform a "laser crossectomy" (flush or zero ablation), which suggests laser fiber position just near the wall of the femoral vein without a traditional 1-2 cm distance from the junction. It is aimed at eliminating the ostia of all adjacent tributaries, including the anterior accessory saphenous vein (AASV), as in a traditional open surgery. To date, the limited evidence of laser crossectomy demonstrates its relative safety and technical feasibility in 57-100%, as well as a contradictory effect on the recurrence rate, including reflux on AASV.
At the same time, the vast majority of studies on laser crossectomy have been conducted at 1.5 μm (1470-1550 nm). The further development of technology has led to devices producing a wavelength of about 2 μm, which exhibit more selective absorption by water in blood and venous walls, allowing a similar depth of wall injury with lower power. First studies on its use show a high occlusion rate of up to 99%, low postoperative pain levels, and a reduced frequency of EHIT (predominantly class 1). Since EHIT of class 1 (superficial vein occlusion up to the level of the deep vein wall) aligns with the intention to perform a laser crossectomy, the use of 2 μm wavelength compared to 1,5 μm can be associated with both improved safety in terms of reducing EHIT of classes 2-4, and lower efficiency due to preservation of a stump with tributaries. Moreover, the technically successful laser crossectomy, despite the reduced risk of reflux recurrence at the SFJ, cannot guarantee the absence of reflux recurrence through other mechanisms. Thus, the question of choosing an optimal wavelength for performing a laser crossectomy, as well as its influence on further progression of GSV reflux, remains open.
- Conditions
- Varicose Veins, Chronic Venous Insufficiency
- Being tested
- Laser crossectomy on 1470 nm, Laser crossectomy on 1940 nm, Standard EVLT with a stump
- Keywords
- Varicose veins, Endovenous laser treatment, Reflux, Recurrence, Crossectomy
- Medical subject headings
- Varicose Veins, Gastroesophageal Reflux, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laser crossectomy on 1470 nmProcedure or surgery
Attempt to perform laser crossectomy with radial fiber (core of 0.4 mm, bulb of 1.57 mm) on the 1470 nm wavelength laser with a power of 6-8 W and an LED of 60-80 J/cm. Performing the GSV trunk ablation according to the indications.
Laser crossectomy on 1940 nmProcedure or surgery
Attempt to perform laser crossectomy with radial fiber (core of 0.55 mm, bulb of 1.4 mm) on the 1940 nm wavelength laser with a power of 4-6 W and an LED of 40-60 J/cm. Performing the GSV trunk ablation according to the indications.
Standard EVLT with a stumpProcedure or surgery
Attempted laser crossectomy on 1470 nm or 1940 nm failed due to anatomical features of the SFJ or technical reasons, and the GSV trunk was obliterated with persistence of the stump.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (1470 nm) | Experimental | Laser crossectomy will be performed with a wavelength of 1470 nm and radial fiber with a core diameter of 0.4 mm and a bulb diameter of 1.57 mm at a power of 6-8 W by manual extraction at a speed of 1 mm/s (LED of 60-80 J/cm). EVLT of the great saphenous vein (GSV) trunk will be performed with a standard approach. Receives: Procedure: Laser crossectomy on 1470 nm |
| Group 2 (1940 nm) | Experimental | Laser crossectomy will be performed with a wavelength of 1940 nm and radial fiber with a core diameter of 0.55 mm and a bulb diameter of 1.4 mm at a power of 4-6 W by manual extraction at a speed of 1 mm/s (LED of 40-60 J/cm). EVLT of the GSV trunk will be performed with a standard approach. Receives: Procedure: Laser crossectomy on 1940 nm |
| Control | Active comparator | Will contain patients who have failed to perform laser crossectomy at 1470 nm or 1940 nm wavelength due to technical impossibility or technical failure, and underwent EVLT of the GSV trunk with preservation of the stump. Receives: Procedure: Standard EVLT with a stump |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with reflux recurrence at the sapheno-femoral junction
Defined as the presence of reflux, with a duration of >0.5 sec under provocation manoeuvre (Valsalva manoeuvre and/or manual distal compression), at the zone of treated SFJ, including reflux on recanalized GSV trunk, on the AASV or any other tributaries, on the lymph node venous network, on the inguinal or perineal veins as detected by duplex ultrasound scan (DUS).
Measured: 12 months
Secondary outcomes (9)
Number of patients with technically possible laser crossectomy
Defined as the possibility of laser fiber positioning near the femoral wall according to the SFJ anatomy during surgery under ultrasound navigation.
Measured: 0 days
Number of patients with technically successful laser crossectomy
Defined as the absence of the GSV stump: ablation level according to the femoral vein wall may vary from +1 mm into the femoral vein lumen to -2 mm into the GSV trunk lumen, as detected by postoperative DUS.
Measured: 3 days
Length of GSV stump
Defined as a distance from the femoral vein wall to the zone of GSV ablation as measured by DUS in mm.
Measured: 12 months
Number of patients with EHIT of 2-4 classes
Defined as thrombus propagation from the GSV trunk into the femoral vein lumen for more than 1 mm as detected by postoperative DUS. Class 2 means thrombus occupying less that 50% of the femoral vein lumen. Class 3 means thrombus occupying more 50% of the femoral vein lumen but not occluding it. Class 4 means occlusive thrombus of the femoral vein.
Measured: 12 months
Number of patients with GSV recanalization
The venous segment of the previously obliterated GSV with blood flow revealed by DUS, and the length of 5 cm or more.
Measured: 12 months
Number of patients with clinical recurrence of varicose veins
The reappearance of the visible or palpable varicose tributaries on any (treated or not-treated) lower limb.
Measured: 12 months
Number of patients with ultrasound recurrence of varicose veins
The appearance of invisible and non-palpable VVs on any (treated or non-treated) limb revealed by a DUS.
Measured: 12 months
The value of VCSS score
The severity of CVD is assessed during clinical examination using the revised Venous Clinical Severity Score (VCSS). Ranges from 0 to 30. A maximal score indicates a more severe CVD.
Measured: 12 months
The value of CIVIQ-20 score
The quality of life is assessed by the patient using the vein-specific Chronic Lower Limb Venous Insufficiency Questionnaire-20 (CIVIQ-20). Range 0-100: a lower score indicates better quality of life.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start20 Jan 2026
- Primary completion20 Jan 2028 (estimated)
- Study completion20 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- An open-label pragmatic randomized controlled trial with 3 parallel groups, where allocation into two experimental groups is performed randomly (wavelength of 1470 or 1940 nm), and the third control group contains subjects for whom a laser crossectomy was technically impossible or failed.
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pirogov Russian National Research Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kirill Lobastov, Pirogov Russian National Research Medical University
- Investigators
- Kirill Lobastov, PhD, Principal investigator, Pirogov Russian National Research Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449728
- Sponsor's protocol ID
- LACROSS-VVP
- Acronym
- LACROSS-VVP
- Status last verified
- Feb 2026
- First submitted
- 26 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Laser Crossectomy With Different Wavelengths on Varicose Vein Progression
- ClinicalTrials.gov ID
- NCT07449728
- Acronym / sponsor ID
- LACROSS-VVP / LACROSS-VVP
- Conditions
- Varicose Veins, Chronic Venous Insufficiency
- Keywords
- Varicose veins, Endovenous laser treatment, Reflux, Recurrence, Crossectomy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Pirogov Russian National Research Medical UniversityUniversity, hospital or other
- Study start
- 20 Jan 2026 (actual)
- Primary completion
- 20 Jan 2028 (estimated)
- Study completion
- 20 Jan 2029 (estimated)
- First posted
- 4 Mar 2026 (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.
Technically successful laser crossectomy will reduce the risk of reflux recurrence at the sapheno-femoral junction without increasing the risk of endovenous heat-induced thrombosis, which may positively impact the likelihood of ultrasound- or clinical-recurrence of varicose veins. Similar technical efficacy is expected for laser crossectomy at 1940 nm and 1470 nm. A possible advantage of the 1940 nm wavelength in terms of postoperative pain intensity and the risk of adverse events cannot be ruled out.
Detailed description
Chronic venous disorder (CVD), including primary varicose veins (VV) of the lower limbs and progressive forms with chronic venous insufficiency (CVI), is an important medical and social problem due to its high prevalence in the population and its significant burden on healthcare systems. According to general data, up to 19% of the population has primary varicose veins, and up to 13.5% has signs of CVI. At present, the main approach to surgical treatment of VVs is the elimination of pathological reflux, for which minimally invasive endovascular techniques are recommended. The latter, including endovascular laser treatment (EVLT), is noninferior to open surgery in technical efficiency but is associated with a lower risk of postoperative complications. Among all adverse events after EVLT, the most important one is venous thromboembolism (VTE), including endovenous heat-induced thrombosis (EHIT). The incidence of EHIT may depend on the position of the laser fiber relative to the sapheno-femoral junction (SFJ).
Recurrent varicose veins, occurring in 10-62% of patients, are the leading consequence of varicose vein surgery in long-term follow-up. The causes of recurrence depend on the type of primary intervention, with recanalization and reflux recurrence at the SFJ after EVLT being the most common.
In order to reduce the risk of varicose veins recurrence, it was proposed to perform a "laser crossectomy" (flush or zero ablation), which suggests laser fiber position just near the wall of the femoral vein without a traditional 1-2 cm distance from the junction. It is aimed at eliminating the ostia of all adjacent tributaries, including the anterior accessory saphenous vein (AASV), as in a traditional open surgery. To date, the limited evidence of laser crossectomy demonstrates its relative safety and technical feasibility in 57-100%, as well as a contradictory effect on the recurrence rate, including reflux on AASV.
At the same time, the vast majority of studies on laser crossectomy have been conducted at 1.5 μm (1470-1550 nm). The further development of technology has led to devices producing a wavelength of about 2 μm, which exhibit more selective absorption by water in blood and venous walls, allowing a similar depth of wall injury with lower power. First studies on its use show a high occlusion rate of up to 99%, low postoperative pain levels, and a reduced frequency of EHIT (predominantly class 1). Since EHIT of class 1 (superficial vein occlusion up to the level of the deep vein wall) aligns with the intention to perform a laser crossectomy, the use of 2 μm wavelength compared to 1,5 μm can be associated with both improved safety in terms of reducing EHIT of classes 2-4, and lower efficiency due to preservation of a stump with tributaries. Moreover, the technically successful laser crossectomy, despite the reduced risk of reflux recurrence at the SFJ, cannot guarantee the absence of reflux recurrence through other mechanisms. Thus, the question of choosing an optimal wavelength for performing a laser crossectomy, as well as its influence on further progression of GSV reflux, remains open.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- An open-label pragmatic randomized controlled trial with 3 parallel groups, where allocation into two experimental groups is performed randomly (wavelength of 1470 or 1940 nm), and the third control group contains subjects for whom a laser crossectomy was technically impossible or failed.
| Arm | Type | Receives |
|---|---|---|
| Group 1 (1470 nm) | Experimental | Procedure: Laser crossectomy on 1470 nmLaser crossectomy will be performed with a wavelength of 1470 nm and radial fiber with a core diameter of 0.4 mm and a bulb diameter of 1.57 mm at a power of 6-8 W by manual extraction at a speed of 1 mm/s (LED of 60-80 J/cm). EVLT of the great saphenous vein (GSV) trunk will be performed with a standard approach. |
| Group 2 (1940 nm) | Experimental | Procedure: Laser crossectomy on 1940 nmLaser crossectomy will be performed with a wavelength of 1940 nm and radial fiber with a core diameter of 0.55 mm and a bulb diameter of 1.4 mm at a power of 4-6 W by manual extraction at a speed of 1 mm/s (LED of 40-60 J/cm). EVLT of the GSV trunk will be performed with a standard approach. |
| Control | Active comparator | Procedure: Standard EVLT with a stumpWill contain patients who have failed to perform laser crossectomy at 1470 nm or 1940 nm wavelength due to technical impossibility or technical failure, and underwent EVLT of the GSV trunk with preservation of the stump. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age >18 years
- Primary VVs of Clinical Etiology Anatomy Pathophysiology (CEAP) clinical class of C2-C6
- Reflux along the GSV trunk lasting >0.5 sec.
- GSV trunk diameter ≤12 mm
- Informed consent to participate in the study
Key exclusion criteria (9 listed)
- Primary reflux outside the GSV trunk (including combined reflux)
- History of deep or superficial vein thrombosis
- Deep vein reflux
- Non-thrombotic or post-thrombotic venous obstruction
- Pelvic venous insufficiency
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 |
|---|---|---|
| Laser crossectomy on 1470 nmAttempt to perform laser crossectomy with radial fiber (core of 0.4 mm, bulb of 1.57 mm) on the 1470 nm wavelength laser with a power of 6-8 W and an LED of 60-80 J/cm. Performing the GSV trunk ablation according to the indications. | Procedure or surgery | Group 1 (1470 nm) |
| Laser crossectomy on 1940 nmAttempt to perform laser crossectomy with radial fiber (core of 0.55 mm, bulb of 1.4 mm) on the 1940 nm wavelength laser with a power of 4-6 W and an LED of 40-60 J/cm. Performing the GSV trunk ablation according to the indications. | Procedure or surgery | Group 2 (1940 nm) |
| Standard EVLT with a stumpAttempted laser crossectomy on 1470 nm or 1940 nm failed due to anatomical features of the SFJ or technical reasons, and the GSV trunk was obliterated with persistence of the stump. | Procedure or surgery | Control |
Primary outcome
Number of patients with reflux recurrence at the sapheno-femoral junction
Time frame: 12 months
Defined as the presence of reflux, with a duration of >0.5 sec under provocation manoeuvre (Valsalva manoeuvre and/or manual distal compression), at the zone of treated SFJ, including reflux on recanalized GSV trunk, on the AASV or any other tributaries, on the lymph node venous network, on the inguinal or perineal veins as detected by duplex ultrasound scan (DUS).
9 secondary outcomes
Number of patients with technically possible laser crossectomy
Time frame: 0 days
Number of patients with technically successful laser crossectomy
Time frame: 3 days
Length of GSV stump
Time frame: 12 months
Number of patients with EHIT of 2-4 classes
Time frame: 12 months
Number of patients with GSV recanalization
Time frame: 12 months
Number of patients with clinical recurrence of varicose veins
Time frame: 12 months
Number of patients with ultrasound recurrence of varicose veins
Time frame: 12 months
The value of VCSS score
Time frame: 12 months
The value of CIVIQ-20 score
Time frame: 12 months
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 4 Mar 2026.
- Individual participant dataSharing planned: No
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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.
Kirill Lobastov, PhD principal investigator
Pirogov Russian National Research Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laser crossectomy on 1470 nm, Laser crossectomy on 1940 nm and Standard EVLT with a stump in people with Varicose Veins and Chronic Venous Insufficiency, run by Pirogov Russian National Research Medical University at 1 site in Russia.
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 5 inclusion and 9 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 4 Mar 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 Russia. 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 Kirill Lobastov, PhD (+79852116331, lobastov_kv@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with reflux recurrence at the sapheno-femoral junction (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Mar 2026.