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. (VNUS vs TULIP)

Ghent University Hospital (UZ)

Status: Completed

Conditions: Chronic Venous Insufficiency C2 or Higher

Treatments: Device: VNUS closure fast; Device: Tulip fiber

Study type: Interventional

Funder types: Other

Identifiers

NCT01722019

2012/693

Details and patient eligibility

About

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,...

Enrollment: 280 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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280 participants in 2 patient groups

radiofrequency ablation with VNUS closure fast

Active Comparator group

Description:

Radiofrequency ablation will be performed with VNUS closure fast.

Treatment:

Device: VNUS closure fast

laser ablation and Tulip fiber

Experimental group

Description:

Laser ablation with a 1470 nm wave length in combination with a new fiber, the Tulip fiber.

Treatment:

Device: Tulip fiber