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NCT Number: NCT01637181

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

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.

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Key information

Conditions

Varicose Veins Cardiovascular Diseases Insufficiency of Great Saphenous Vein Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasmus Medical Center

Rotterdam, 3015 CA, Netherlands

About this study

  • 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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Endovenous laser ablation (EVLA)

Procedure

EVLA with 940 nm Diode laser EVLA with 1470 nm Nd:Yag laser With both devices, obliteration of the varicose vein is obtained by heating the vein, using emission of laser light.

Primary outcomes

  1. Pain score and use of painkillers

    Time frame: 1 week post treatment

    A questionnaire including a numeric rating scale (NRS) of pain is filled in by the patient.

  2. Treatment satisfaction

    Time frame: 1 week post treatment

    A NRS of satisfaction is filled in by the patient.

  3. Health related quality of life

    Time frame: 0 and 12 weeks post treatment

    Dutch Translated Aberdeen Varicose Vein Questionnaire (AVVQ) and EQ-5D questionnaire are filled in by the patient.

Secondary outcomes

  1. Number of participants with adverse events

    Time frame: The adverse events will be assessed at 1 and 12 weeks post treatment.

    Minor complications: ecchymoses and hyperpigmentation. Major complications: deep and superficial venous thrombosis (embolic events), nerve injury, skin burns, and (sub)cutaneous infections.

  2. Occlusion of the treated GSV (effectiveness)

    Time frame: The rates will be compared between 940 nm and 1470 nm endovenous laser at time 1, 12 and 52 weeks post treatment.

    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.

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

Comparative Randomized Clinical Trial of Endovenous 940 nm Laser Ablation Versus Endovenous 1470 nm Laser Ablation for Treatment of Great Saphenous Veins

Acronym: COLA

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jul 11, 2012
Registry last updated
Feb 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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