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.

N/ACompletedNCT01722019

University Hospital, Ghent280 enrolled

Overview

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,…

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

280

Conditions

Chronic Venous Insufficiency C2 or Higher

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (3)

Ghent University Hospital

Ghent, Belgium

University Hospital Leuven

Leuven, Belgium

Sint-Andriesziekenhuis Tielt

Tielt, Belgium

Outcomes

Primary Outcomes

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.

Time frame: 12 months after procedure