Treatment of Varicose Veins With the ELVeS® Radial® 2ring Slim Fiber. Are There Limitations?

Study Overview
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Brief Summary
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This study aims to prove that the ELVeS® Radial® 2ring slim fiber is safe and effective in endovenous laser ablation (EVLA) of varicose veins, with a reliable durability by evaluating procedural details/outcomes, clinical success, anatomic success, pain, post-operative adverse events and re-interventions.

Official Title
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Treatment of Varicose Veins With the ELVeS® Radial® 2ring Slim Fiber. Are There Limitations?

Conditions
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Varicose Veins

Intervention / Treatment
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* Device: ELVeS® Radial® 2ring slim fiber


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patient is at least 18 years old. Patient must sign and date the informed consent form prior to treatment. Presence of unilateral or bilateral primary symptomatic varicose veins (CEAP grade ≥ C2). Patient has an insufficient Great Saphenous Vein (GSV), with or without laser ablation of anterior accessory saphenous vein (AASV), posterior accessory saphenous vein (PASV), and/or Small Saphenous Vein (SSV), with venous symptoms (valve incompetence), suitable for endovenous laser ablation (EVLA). Maximum diameter of the to be treated veins is ≤ 14mm. Exclusion Criteria: Current deep vein thrombosis. Acute superficial thrombosis. Mean diameter of the to be treated veins > 14mm. Tortuous or very superficial veins considered unsuitable for laser treatment. Recurrent varicose veins. Pregnancy. Coagulopathy or bleeding disorders. Contraindications to the use of general or regional anesthesia.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with varicose veins, eligible for EVLA<br> | Device: ELVeS® Radial® 2ring slim fiber<br>* Device for endovenous laser ablation manufactured by Biolitec AG company (ELVeS system) - diode laser with a wavelength of 1470 nm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anatomic success | defined as occlusion of the treated veins and lack of reflux objectified with duplex ultrasonography | at 1 month follow-up | 
| Anatomic success | defined as occlusion of the treated veins and lack of reflux objectified with duplex ultrasonography | at 12 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural characteristics | Details concerning the index-procedure | at index-procedure | 
| Pain scoring using the Visual Analog Scale (VAS) | The VAS scale contains a 0 - 100 grading with 0 equaling no pain and 100 equaling the worst conceivable pain. The patient is asked to select the number on the scale that corresponds to the worst level of pain he/she experiences. Pain is classified into mild (1 - 30 mm), moderate (31 - 60 mm) and severe (61 - 100 mm). Absence of pain is defined as VAS = 0. | discharge | 
| Pain scoring using the Visual Analog Scale (VAS) | The VAS scale contains a 0 - 100 grading with 0 equaling no pain and 100 equaling the worst conceivable pain. The patient is asked to select the number on the scale that corresponds to the worst level of pain he/she experiences. Pain is classified into mild (1 - 30 mm), moderate (31 - 60 mm) and severe (61 - 100 mm). Absence of pain is defined as VAS = 0. | at 1 week follow-up | 
| Clinical success, defined as an objective improvement of clinical outcome after treatment, measured with the Venous Clinical Severity Score (VCSS) | The VCSS includes 9 hallmarks of venous disease, each scored on a severity scale from 0 to 3. | at 1 month follow-up | 
| Clinical success, defined as an objective improvement of clinical outcome after treatment, measured with the Venous Clinical Severity Score (VCSS) | The VCSS includes 9 hallmarks of venous disease, each scored on a severity scale from 0 to 3. | at 12 months follow-up | 
| Post-operative adverse events | numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc. | at 1 week follow-up | 
| Post-operative adverse events | numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc. | at 1 month follow-up | 
| Post-operative adverse events | numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc. | at 12 months follow-up | 
| Re-interventions | including reason for re-intervention and description of treatment | at 1 week follow-up | 
| Re-interventions | including reason for re-intervention and description of treatment | at 1 month follow-up | 
| Re-interventions | including reason for re-intervention and description of treatment | at 12 months follow-up |