Chronic Venous Insufficiency C2 or Higher
Conditions
Keywords
venous insufficiency
Brief summary
Endovenous ablation of the greater saphenous vein has nowadays the same outcome as open crossectomy and stripping. The two most performed techniques for endovenous ablation are the endovenous laser ablation and the radiofrequency ablation. According to the trial of Rasmussen, they are equivalent for occlusion but the lower laser wave lengths resulted in more pain and paresthesia. The newer wave length of 1470 nm showed lesser side effects in observational studies. The aim of this study is to compare radiofrequency ablation with the VNUS closure fast ® with laser ablation with a 1470 nm wave length in combination with a new fiber, the Tulip fiber ®. This fiber has the shape of a tulip at his tip which avoids point necroses of the vessel wall and on consequence results in lesser side effects from wall perforations such as pain, haematoma,…
Interventions
DEVICETulip fiber
Laser ablation with a wavelength of 1470 nanometers will be performed, in combination with a new sort of fiber: the tulip tip fiber.
DEVICEVNUS closure fast
Radiofrequent ablation will be performed in combination with the catheter 'VNUS closure fast'.
Sponsors
European Venous Forum.
Benelux Society of Phlebology.
University Hospital, Ghent
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Endovenous ablation of the great saphenous vein (GSV) planned * Patient signed informed consent * Patient must complete the 1 year follow-up * CEAP between 2 and 6 * BMI=\<35 * Diameter of the GSV in upward position less than 20 mm diameter * No problems in deep venous system
Exclusion criteria
* No informed consent is signed * Latex allergy * Arterial insufficiency * Deep vein thrombosis or deep vein insufficiency * Klippel Trenaunay * Diameter fo GSV \> 20 mm * Cross dilation with 2 or more insufficient side branches * Previous GSV operation * Redo-operation * Carcinoma less than 1 year ago * BMI \> 35 * Liver-insufficiency with contraindication for local tumescence * Intake of warfarins * Pregnancy, breastfeeding, \< 3 months after pregnancy * Bilateral GSV insufficiency that has to be treated * Cross insufficiency of the accessory saphenous vein or insufficiency of the subterminal valve of the GSV
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Closure of the greater saphenous vein at 12 months. | 12 months after procedure | Closure of the greater saphenous vein will be measured by venous duplex, Kabnick score and modified Gelev score. This will be performed after 5 days, 1 month, 6 months and 12 months. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pain. | after 5 days | This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score. |
| Patient satisfaction rate. | after 5 days | This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score. |
| Pain satisfaction rate. | After 6 months | This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score. |
| Incapacity to work. | after 5 days | This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score. |
Countries
Belgium
Outcome results
None listed