The Influence of Laser Crossectomy With Different Wavelengths on Varicose Vein Progression
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Russian Federation
MedSwiss Private Cinic
RECRUITING
Moscow
Contact Information
Primary
Kirill Lobastov, PhD
lobastov_kv@hotmail.com
+79852116331
Time Frame
Start Date: 2026-01-20
Estimated Completion Date: 2029-01-20
Participants
Target number of participants: 400
Treatments
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.
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.
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.
Related Therapeutic Areas
Sponsors
Leads: Pirogov Russian National Research Medical University