The Influence of Laser Crossectomy With Different Wavelengths on Varicose Vein Progression
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPirogov Russian National Research Medical University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Laser crossectomy on 1470 nm
Procedure/SurgeryAttempt 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.
Laser crossectomy on 1940 nm
Procedure/SurgeryAttempt 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.
Standard EVLT with a stump
Procedure/SurgeryAttempted 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.
Treatment groups
400 Participants
are divided into 3 treatment groupsGroup A: Group 1 (1470 nm)Experimental treatment 1 intervention
Group B: Group 2 (1940 nm)Experimental treatment 1 intervention
Group C: ControlActive comparator 1 intervention
Trial outcomes
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).
Time frame
12 monthsSecondary outcomes
1
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 days2
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 days3
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 months4
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 monthsSponsors and contacts
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Source ClinicalTrials.gov