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.

NCT01722019 | Completed

• 1 other identifier: 2012/693
• Study Type: interventional
• Target: 280
• Locations: 1 country
• Sites: 3

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,…

Conditions

Chronic Venous Insufficiency C2 or Higher

Keywords

venous insufficiency

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (15)

• Pain.

  after 5 days

• Pain.

  after 14 days

• Pain.

  after 1 month

• Pain.

  after 6 months

• Pain.

  after 1 year.

Study Arms (2)

radiofrequency ablation with VNUS closure fast

ACTIVE COMPARATOR

Radiofrequency ablation will be performed with VNUS closure fast.

Device: VNUS closure fast

laser ablation and Tulip fiber

EXPERIMENTAL

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

Device: Tulip fiber

Interventions

Tulip fiber DEVICE

Laser ablation with a wavelength of 1470 nanometers will be performed, in combination with a new sort of fiber: the tulip tip fiber.

laser ablation and Tulip fiber

VNUS closure fast DEVICE

Radiofrequent ablation will be performed in combination with the catheter 'VNUS closure fast'.

radiofrequency ablation with VNUS closure fast

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ghent: lead
• European Venous Forum.: collaborator
• Benelux Society of Phlebology.: collaborator

Study Sites (3)

Ghent University Hospital

Ghent, 9000, Belgium

Location

University Hospital Leuven

Leuven, 3000, Belgium

Location

Sint-Andriesziekenhuis Tielt

Tielt, 8700, Belgium

Location

Related Links

• Related Info

MeSH Terms

Conditions

Venous Insufficiency

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Carend Randon, MD, PhD

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 29, 2012
• First Posted: November 6, 2012
• Study Start: January 1, 2014
• Primary Completion: August 31, 2022
• Study Completion: August 31, 2022
• Last Updated: December 29, 2022

Record last verified: 2022-12

Locations

BE (3)