Treatment of Varicose Veins With the ELVeS® Radial® 2ring Slim Fiber. Are There Limitations?

Completed

• Conditions: Varicose Veins
• Interventions: Device: ELVeS® Radial® 2ring slim fiber

• Registration Number: NCT03810677
• Lead Sponsor: be Medical

Brief Summary

This study aims to prove that the ELVeS® Radial® 2ring slim fiber is safe and effective in endovenous laser ablation (EVLA) of varicose veins, with a reliable durability by evaluating procedural details/outcomes, clinical success, anatomic success, pain, post-operative adverse events and re-interventions.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-11
• Study First Submitted QC: 2019-01-17
• Study First Posted: 2019-01-22
• Study Start: 2019-04-15
• Primary Completion: 2021-03-08
• Study Completion: 2021-03-08
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-30
• Last Update Posted: 2021-05-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Patient is at least 18 years old.
2. Patient must sign and date the informed consent form prior to treatment.
3. Presence of unilateral or bilateral primary symptomatic varicose veins (CEAP grade ≥ C2).
4. Patient has an insufficient Great Saphenous Vein (GSV), with or without laser ablation of anterior accessory saphenous vein (AASV), posterior accessory saphenous vein (PASV), and/or Small Saphenous Vein (SSV), with venous symptoms (valve incompetence), suitable for endovenous laser ablation (EVLA).
5. Maximum diameter of the to be treated veins is ≤ 14mm.

Exclusion Criteria

1. Current deep vein thrombosis.
2. Acute superficial thrombosis.
3. Mean diameter of the to be treated veins > 14mm.
4. Tortuous or very superficial veins considered unsuitable for laser treatment.
5. Recurrent varicose veins.
6. Pregnancy.
7. Coagulopathy or bleeding disorders.
8. Contraindications to the use of general or regional anesthesia.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with varicose veins, eligible for EVLA	ELVeS® Radial® 2ring slim fiber	-

Primary Outcome Measures

Name	Time	Method
Anatomic success	at 12 months follow-up	defined as occlusion of the treated veins and lack of reflux objectified with duplex ultrasonography

Secondary Outcome Measures

Name	Time	Method
Clinical success, defined as an objective improvement of clinical outcome after treatment, measured with the Venous Clinical Severity Score (VCSS)	at 12 months follow-up	The VCSS includes 9 hallmarks of venous disease, each scored on a severity scale from 0 to 3.
Post-operative adverse events	at 12 months follow-up	numbness, persistent bruising, skin loss or ulceration, hematoma, infection, bleeding, deep venous thrombosis, etc.
Procedural characteristics	at index-procedure	Details concerning the index-procedure
Pain scoring using the Visual Analog Scale (VAS)	at 1 week follow-up	The VAS scale contains a 0 - 100 grading with 0 equaling no pain and 100 equaling the worst conceivable pain. The patient is asked to select the number on the scale that corresponds to the worst level of pain he/she experiences. Pain is classified into mild (1 - 30 mm), moderate (31 - 60 mm) and severe (61 - 100 mm). Absence of pain is defined as VAS = 0.
Re-interventions	at 12 months follow-up	including reason for re-intervention and description of treatment

Trial Locations

Locations (2)

Imelda Hospital; 🇧🇪 Bonheiden, Antwerp, Belgium

Jessa Hospital; 🇧🇪 Hasselt, Limburg, Belgium