Varicose Veins
Conditions
Brief summary
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.
Interventions
DEVICEELVeS® Radial® 2ring slim fiber
Device for endovenous laser ablation manufactured by Biolitec AG company (ELVeS system) - diode laser with a wavelength of 1470 nm
Sponsors
Biolitec AG
be Medical
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient is at least 18 years old. 2. Patient must sign and date the informed consent form prior to treatment. 3. Presence of unilateral or bilateral primary symptomatic varicose veins (CEAP grade ≥ C2). 4. 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). 5. Maximum diameter of the to be treated veins is ≤ 14mm.
Exclusion criteria
1. Current deep vein thrombosis. 2. Acute superficial thrombosis. 3. Mean diameter of the to be treated veins \> 14mm. 4. Tortuous or very superficial veins considered unsuitable for laser treatment. 5. Recurrent varicose veins. 6. Pregnancy. 7. Coagulopathy or bleeding disorders. 8. Contraindications to the use of general or regional anesthesia.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anatomic success | at 1 month follow-up | defined as occlusion of the treated veins and lack of reflux objectified with duplex ultrasonography |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedural characteristics | at index-procedure | Details concerning the index-procedure |
| Pain scoring using the Visual Analog Scale (VAS) | discharge | 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. |
| Clinical success, defined as an objective improvement of clinical outcome after treatment, measured with the Venous Clinical Severity Score (VCSS) | at 1 month follow-up | The VCSS includes 9 hallmarks of venous disease, each scored on a severity scale from 0 to 3. |
| Post-operative adverse events | at 1 week follow-up | numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc. |
| Re-interventions | at 1 week follow-up | including reason for re-intervention and description of treatment |
Countries
Belgium
Outcome results
None listed