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Recruiting NCT07449728

The Influence of Laser Crossectomy With Different Wavelengths on Varicose Vein Progression

No phase Interventional Varicose Veins Chronic Venous Insufficiency

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Laser crossectomy on 1470 nm, Laser crossectomy on 1940 nm, Standard EVLT with a stump.
Who it may be relevant to
Registry conditions: Varicose Veins, Chronic Venous Insufficiency. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Russia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • 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.
  • 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.
  • 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.

Primary outcome measures

  • Number of patients with reflux recurrence at the sapheno-femoral junction [Time frame: 12 months]
Secondary outcome measures (9)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Russia · 1 center
  • MedSwiss Private Cinic — Moscow

Identifiers

NCT: NCT07449728 · LACROSS-VVP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗