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

NCT07449728 | Recruiting

• 1 other identifier: LACROSS-VVP
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Varicose Veins; Chronic Venous Insufficiency

Keywords

Varicose veins; Endovenous laser treatment; Reflux; Recurrence; Crossectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (9)

• Number of patients with technically possible laser crossectomy

  0 days

• Number of patients with technically successful laser crossectomy

  3 days

• Length of GSV stump

  12 months

• Number of patients with EHIT of 2-4 classes

  12 months

• Number of patients with GSV recanalization

  12 months

Study Arms (3)

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.

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.

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.

Procedure: Standard EVLT with a stump

Interventions

Laser crossectomy on 1470 nm PROCEDURE

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.

Group 1 (1470 nm)

Laser crossectomy on 1940 nm PROCEDURE

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.

Group 2 (1940 nm)

Standard EVLT with a stump PROCEDURE

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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Pirogov Russian National Research Medical University: lead

Study Sites (1)

MedSwiss Private Cinic

Moscow, 143082, Russia

RECRUITING

MeSH Terms

Conditions

Varicose Veins; Gastroesophageal Reflux; Recurrence

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kirill Lobastov, PhD

  Pirogov Russian National Research Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kirill Lobastov, PhD

CONTACT

+79852116331; lobastov_kv@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of the Department of General surgery named after V.M. Buyanov

Model Details: 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.

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 4, 2026
• Study Start: January 20, 2026
• Primary Completion (Estimated): January 20, 2028
• Study Completion (Estimated): January 20, 2029
• Last Updated: March 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)