Three Different Regimens of Endovenous Laser Ablation With Equal Linear Endovenous Energy Density (The SLEDGE Study): a Prospective, Randomized Multicenter Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Varicose Veins
- Sponsor
- Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
- Enrollment
- 203
- Locations
- 2
- Primary Endpoint
- The number of participants with a fully obliterated target vein
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief 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.
Investigators
Denis Borsuk
Chief surgeon
Clinic of Phlebology and Laser Surgery, Chelyabinsk, Russia
Eligibility Criteria
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
Outcomes
Primary Outcomes
The number of participants with a fully obliterated target vein
Time Frame: 3 month
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.
Secondary Outcomes
- Pain score(day 7)