The Effect of Laser Power and Fiber Traction Speed on the Outcomes of Endovenous Laser Ablation (SLEDGE)

Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia

Status: Completed

Conditions: Varicose Veins

Treatments: Device: Laser; Procedure: Endovenous laser ablation (EVLA)

Study type: Interventional

Funder types: Other

Identifiers

NCT03037827

A001

Details and patient eligibility

About

A multicenter clinical randomized controlled trial, comparing of three different regimens of endovenous laser ablation with equal linear endovenous energy density in patients with insufficiency of the great saphenous vein (GSV). The linear endovenous energy density (LEED) is the main value for standardization EVLA. From many studies, it is known the optimum value of the LEED. However, the same LEED may be obtained by varying the ratio between the laser power and the fiber pullback speed. Power decrease can allow to reduce the incidence of adverse effects of endovenous laser ablation, but keep high efficiency.

Enrollment: 203 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients over 18 years old Insufficiency of the GSV measured with ultrasound imaging, reflux > 0.5 sec No prior treatment of the insufficient GSV Informed consent

Exclusion criteria

Acute deep or superficial vein thrombosis Agenesis of deep vein system Vascular malformation or syndrome Post-thrombotic syndrome, occlusive type Pregnancy Phlebectomy on the thigh Immobility Allergy to lidocaine Arterial insufficiency

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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203 participants in 3 patient groups

Endovenous laser ablation (EVLA) 5W

Active Comparator group

Description:

One of three different regimens of endovenous laser ablation, the fiber pullback speed 0.7 mm/s, laser power 5 W, LEED 71 J/cm

Treatment:

Procedure: Endovenous laser ablation (EVLA)

Device: Laser

Endovenous laser ablation (EVLA) 7W

Active Comparator group

Description:

One of three different regimens of endovenous laser ablation, the fiber pullback speed 1 mm/s, laser power 7 W, LEED 70 J/cm

Treatment:

Procedure: Endovenous laser ablation (EVLA)

Device: Laser

Endovenous laser ablation (EVLA) 10W

Active Comparator group

Description:

One of three different regimens of endovenous laser ablation, the fiber pullback speed 1.5 mm/s, laser power 10 W, LEED 67 J/cm

Treatment:

Procedure: Endovenous laser ablation (EVLA)

Device: Laser