An interventional study of Laser crossectomy on 1470 nm and Laser crossectomy on 1940 nm in Varicose Veins and Chronic Venous Insufficiency, sponsored by Pirogov Russian National Research Medical University. Recruiting at 1 site in Russia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-04.
Sponsored by Pirogov Russian National Research Medical University · Not applicable, Interventional, and Treatment
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.
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.
226 studies on the registry are indexed under Varicose Veins; 30 are open to participants now.
This study's planned enrollment of 400 is above the median of 101 across 154 interventional studies indexed under Varicose Veins.
Browse Varicose Veins studies →Pirogov Russian National Research Medical University is the lead sponsor of 57 studies on the registry; 15 are open to participants now.
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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.
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
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
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
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.
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.
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.
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).
Time frame: 12 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 12 months
Plan to share: No
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Pirogov Russian National Research Medical University