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

Varicose Veins Clinical Trial

— SLEDGE  

Official title:

Three Different Regimens of Endovenous Laser Ablation With Equal Linear Endovenous Energy Density (The SLEDGE Study): a Prospective, Randomized Multicenter Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03037827
• Other study ID #: A001
• Status: Completed
• Phase: N/A
• Start date: January 30, 2017
• Est. completion date: May 19, 2021

Study information

• Verified date: May 2021
• Source: Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 203
• Est. completion date: May 19, 2021
• Est. primary completion date: May 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Varicose Veins

Intervention

Procedure:
• Endovenous laser ablation (EVLA)
Endovenous laser ablation with laser wavelength 1470 nm and radial laser fiber

Device:
• Laser
Device for endovenous laser ablation manufactured by Biolitec AG company (ELVeS system) - diode laser with a wavelength of 1470 nm

Locations

Country	Name	City	State
Russian Federation	Clinic of Phlebology and Laser Surgery	Chelyabinsk
Russian Federation	GarantClinic	Moscow

Sponsors (3)

Lead Sponsor	Collaborator
Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia	Garantclinic, Medalp Private Surgery Clinic

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Number of patients with adverse events		3 month
Other	Paresthesia		3 month
Other	Deep venous thrombosis		day 7
Other	Superficial venous thrombosis		day 7
Primary	The number of participants with a fully obliterated target vein	An ultrasound investigation of the treated vein to find out is the treated vein is fully obliterated or not, and to find out is there any pathological reflux in the vein.	3 month
Secondary	Pain score	Pain (numeric rating scale)	day 1
Secondary	Pain score	Pain (numeric rating scale)	day 7

External Links

•   the Russian Registry of Treatment of Chronic Venous Diseases (RRT CVD). ClinicalTrials.gov ID: NCT03035747