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

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

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.

Study Overview

• Status: Completed
• Conditions: Varicose Veins
• Intervention / Treatment: Procedure: Endovenous laser ablation (EVLA); Device: Laser

• Study Type: Interventional
• Enrollment (Actual): 203
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Chelyabinsk, Russian Federation
    • Clinic of phlebology and laser surgery
  • Moscow, Russian Federation
    • GarantClinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Endovenous laser ablation (EVLA) 5W; 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	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
Active Comparator: Endovenous laser ablation (EVLA) 7W; One of three different regimens of endovenous laser ablation, the fiber pullback speed 1 mm/s, laser power 7 W, LEED 70 J/cm	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
Active Comparator: Endovenous laser ablation (EVLA) 10W; 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	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain score	Pain (numeric rating scale)	day 1
Pain score	Pain (numeric rating scale)	day 7

Other Outcome Measures

Outcome Measure	Time Frame
Number of patients with adverse events	3 month
Paresthesia	3 month
Deep venous thrombosis	day 7
Superficial venous thrombosis	day 7

Collaborators and Investigators

• Sponsor: Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
• Collaborators: Medalp Private Surgery Clinic; Garantclinic

Publications and helpful links

Helpful Links

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

Study record dates

Study Major Dates

• Study Start (Actual): January 30, 2017
• Primary Completion (Actual): May 19, 2021
• Study Completion (Actual): May 19, 2021

Study Registration Dates

• First Submitted: January 29, 2017
• First Submitted That Met QC Criteria: January 30, 2017
• First Posted (Estimate): January 31, 2017

Study Record Updates

• Last Update Posted (Actual): May 20, 2021
• Last Update Submitted That Met QC Criteria: May 19, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: endovenous laser ablation; radial fiber; linear endovenous energy density; 1470 nm; occlusion rate
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Varicose Veins
• Other Study ID Numbers: A001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Data collection will take place at the Russian Registry of Treatment of Chronic Venous Diseases (RRT CVD). Access to the data will be available after completion of the study. To access the data will need to send a request to RRT CVD administrator. Register in Russian. Registry now listed in the database ClinicalTrials.gov, ID NCT03035747 (see references)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No