Clinical trial NCT03810677: Treatment of Varicose Veins With the ELVeS® Radial® 2ring Slim Fiber. Are There Limitations?
Official title: Treatment of Varicose Veins With the ELVeS® Radial® 2ring Slim Fiber. Are There Limitations?
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Varicose Veins
Lead sponsor: be Medical
Sponsor class: INDUSTRY
Collaborators: name: Biolitec AG
First posted: 2019-01-22
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 150 patients with varicose veins, eligible for treatment with EndoVenous Laser Ablation (EVLA).

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Anatomic success
timeFrame: at 1 month follow-up
measure: Anatomic success
timeFrame: at 12 months follow-up
Secondary outcomes:
measure: Procedural characteristics
timeFrame: at index-procedure
measure: Pain scoring using the Visual Analog Scale (VAS)
timeFrame: discharge
measure: Pain scoring using the Visual Analog Scale (VAS)
timeFrame: at 1 week follow-up
measure: Clinical success, defined as an objective improvement of clinical outcome after treatment, measured with the Venous Clinical Severity Score (VCSS)
timeFrame: at 1 month follow-up
measure: Clinical success, defined as an objective improvement of clinical outcome after treatment, measured with the Venous Clinical Severity Score (VCSS)
timeFrame: at 12 months follow-up
measure: Post-operative adverse events
timeFrame: at 1 week follow-up
measure: Post-operative adverse events
timeFrame: at 1 month follow-up
measure: Post-operative adverse events
timeFrame: at 12 months follow-up
measure: Re-interventions
timeFrame: at 1 week follow-up
measure: Re-interventions
timeFrame: at 1 month follow-up
measure: Re-interventions
timeFrame: at 12 months follow-up
Other outcomes:
Locations:
city: Bonheiden
country: Belgium
facility: Imelda Hospital
state: Antwerp
city: Hasselt
country: Belgium
facility: Jessa Hospital
state: Limburg
Study officials:
References: