Prospective Multicentric Trial Between Radiofrequency Ablation With VNUS Closure Fast ® and Endovenous Ablation With 1470 nm Diode Laser and Tulip Fiber ® for Treatment of Primary Venous Insufficiency.

Study Overview
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Brief Summary
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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,…

Official Title
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Prospective Multicentric Randomised Trial Between Radiofrequency Ablation With VNUS Closure Fast ® and Endovenous Ablation With 1470 nm Diod Laser and Tulip Fiber ® for Treatment of Primary Venous Insufficiency.

Conditions
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Chronic Venous Insufficiency C2 or Higher

Intervention / Treatment
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* Device: Tulip fiber
* Device: VNUS closure fast


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: radiofrequency ablation with VNUS closure fast<br>Radiofrequency ablation will be performed with VNUS closure fast. | Device: VNUS closure fast<br>* Radiofrequent ablation will be performed in combination with the catheter 'VNUS closure fast'.<br>|
| Experimental: laser ablation and Tulip fiber<br>Laser ablation with a 1470 nm wave length in combination with a new fiber, the Tulip fiber. | Device: Tulip fiber<br>* Laser ablation with a wavelength of 1470 nanometers will be performed, in combination with a new sort of fiber: the tulip tip fiber.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Closure of the greater saphenous vein at 12 months. | 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. | 12 months after procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain. | This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score. | after 5 days | 
| Pain. | This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score. | after 14 days | 
| Pain. | This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score. | after 1 month | 
| Pain. | This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score. | after 6 months | 
| Pain. | This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score. | after 1 year. | 
| Patient satisfaction rate. | This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score. | after 5 days | 
| Patient satisfaction rate. | This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score. | After 14 days. | 
| Patient satisfaction rate. | This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score. | After 1 month | 
| Pain satisfaction rate. | This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score. | After 6 months | 
| Patient satisfaction rate. | This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score. | After 1 year. | 
| Incapacity to work. | This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score. | after 5 days | 
| Incapacity to work. | This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score. | After 14 days | 
| Incapacity to work. | This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score. | After 1 month | 
| Incapacity to work. | This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score. | After 6 months | 
| Incapacity to work. | This will be measured with the VAS score, VCSS score, CIVIQ score, clinical evaluation and hematoma score. | After 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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venous insufficiency