Clinical Trial of Endovenous 940 and 1470 Laser Ablation for Treating Great Saphenous Veins (COLA)

Erasmus University

Status: Completed

Conditions: Insufficiency of Great Saphenous Vein; Varicose Veins

Treatments: Procedure: Endovenous laser ablation (EVLA)

Study type: Interventional

Funder types: Other

Identifiers

NCT01637181

NL38160.078.11

Details and patient eligibility

About

A clinical randomized controlled trial, comparing 2 endovenous laser ablation (EVLA) techniques in patients with insufficiency of the great saphenous vein (GSV). There are multiple EVLA devices available, with different wavelengths. In the Netherlands, 940 nm Diode and 1470 nm Nd:Yag laser are the most frequently used devices. Both devices also proven to be equally effective in occluding the GSV. However, little is known about differences in patient-related outcomes. Therefore, the primary outcomes of this comparative clinical trial of 940 nm and 1470 nm EVLA, are pain scores, patient satisfaction and scores of health related and varicose-specific questionnaires. The secondary outcomes are complications and effectiveness of the treatment. It is thought that possibly the 1470 nm ELVA will give lower pain scores and higher patient satisfaction than 940 nm EVLA. No differences are expected in complication rate and effectiveness between the two treatments.

Full description

* Study type: Interventional. Randomized comparative clinical trial..

• Outcome measures:

  • Primary study outcomes: Patient reported outcomes: 1. Pain score and use of painkillers, assessed with a numeric rating scale (NRS) of pain. 2. Treatment satisfaction, assessed with a NRS of satisfaction. 3. Health related quality of life, assessed with Dutch translated Aberdeen Varicose Vein Questionnaire (AVVQ) and EQ-5D questionnaire.
  • Secondary study outcomes: 1. Number of patients with adverse events. Major complications: deep and superficial venous thrombosis (embolic events), nerve injury, skin burns, and (sub)cutaneous infections. Minor complications: ecchymosis and hyperpigmentation. 2. Obliteration of varicose vein and/or absence of reflux (> 0.5 sec. of retrograde flow) along the treated segment of the GSV. This is measured using US examination.

• Outcome measures time frame:

Follow-up of one year, with outcome measures at baseline, 1 week, 3 months and 1 year post treatment.

* Focus of the study: Varicose great saphenous veins (GSV)

• Intervention information:

  • Intervention name: endovenous laser ablation (EVLA)
  • Intervention type: 1. EVLA with 940 nm Diode laser 2. EVLA with 1470 nm Nd:Yag laser
  • Arm information: both interventions are active comparators.

• Locations:

Rotterdam, Zuid-Holland, The Netherlands

Enrollment: 142 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients over 18 years old
• Insufficiency of the GSV measured with ultrasound imaging, reflux > 0.5 sec, and diameter of vein > 0.5 cm
• Symptoms of chronic venous insufficiency, including complaints related to varicose veins (≥ C2)
• No prior treatment of the insufficient GSV
• Informed consent

Exclusion criteria

• Acute deep or superficial vein thrombosis
• Agenesis of deep vein system
• Vascular malformation or syndrome
• Post-thrombotic syndrome, occlusive type
• Pregnancy
• Immobility
• Allergy to lidocaine
• Arterial insufficiency
• Diameter of GSV ≤ 0.5 mm at puncture site

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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142 participants in 2 patient groups

EVLA 940 nm

Active Comparator group

Treatment:

Procedure: Endovenous laser ablation (EVLA)

EVLA 1470 nm

Active Comparator group

Treatment:

Procedure: Endovenous laser ablation (EVLA)