The Influence of Laser Crossectomy With Different Wavelengths on Varicose Vein Progression (LACROSS-VVP)

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.

Study Overview

• Status: Recruiting
• Conditions: Varicose Veins; Chronic Venous Insufficiency
• Intervention / Treatment: Procedure: Laser crossectomy on 1470 nm; Procedure: Laser crossectomy on 1940 nm; Procedure: Standard EVLT with a stump

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 Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kirill Lobastov, PhD; Phone Number: +79852116331; Email: lobastov_kv@hotmail.com

Study Locations

• Russia
  • Moscow, Russia, 143082
    • Recruiting
    • MedSwiss Private Cinic
    • Contact: Kirill Lobastov, PhD; Phone Number: +7-985-211-63-31; Email: lobastov_kv@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group 1 (1470 nm); 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.	Procedure: Laser crossectomy on 1470 nm; 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.
Experimental: Group 2 (1940 nm); 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.	Procedure: Laser crossectomy on 1940 nm; 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.
Active Comparator: Control; 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.	Procedure: Standard EVLT with a stump; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	12 months

Collaborators and Investigators

• Sponsor: Pirogov Russian National Research Medical University
• Investigators: Principal Investigator: Kirill Lobastov, PhD, Pirogov Russian National Research Medical University

Study record dates

Study Major Dates

• Study Start (Actual): January 20, 2026
• Primary Completion (Estimated): January 20, 2028
• Study Completion (Estimated): January 20, 2029

Study Registration Dates

• First Submitted: February 26, 2026
• First Submitted That Met QC Criteria: February 26, 2026
• First Posted (Actual): March 4, 2026

Study Record Updates

• Last Update Posted (Actual): March 4, 2026
• Last Update Submitted That Met QC Criteria: February 26, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Recurrence; Reflux; Varicose veins; Endovenous laser treatment; Crossectomy
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Disease Attributes; Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Pathological Conditions, Signs and Symptoms; Recurrence; Gastroesophageal Reflux; Varicose Veins
• Other Study ID Numbers: LACROSS-VVP

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No