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NCT Number: NCT02046967

Steam Ablation Versus Endovenous Laser Ablation for the Treatment of Great Saphenous Veins

Endovenous laser ablation is a common therapy of great saphenous vein insufficiency with a very high success rate. It works by heating and thereby obliterating the vein. Steam ablation is a new therapy that also works by heating and thereby obliterating the vein. The hypothesis of this study is that steam ablation is as effective as laser ablation, but that it results in better secondary outcomes (e.g., lower pain scores).

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Key information

Conditions

Varicose Veins Cardiovascular Diseases Varicose Veins of Leg With Long Saphenous Vein Distribution Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasmus MC

Rotterdam, 3015 CA, Netherlands

About this study

The study is a randomized clinical trial comparing two different therapies for endovenous ablation of great saphenous veins. The aim of the study is to test whether the anatomical success rate of Steam Ablation is not inferior to that of Endovenous laser ablation (EVLA) in treatment of great saphenous vein insufficiency and compare the treatment safety, patient reported outcomes and cost-effectiveness analyses between EVLA and Steam Ablation.

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 s, and diameter of vein > 0.5 cm
  • Symptoms of chronic venous insufficiency
  • 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

Treatment and study plan

Endovenous laser ablation with 940 nm bare fiber

Procedure

Endovenous laser ablation with 940 nm Diode laser using a bare fiber for treating the Great Saphenous Vein.

Other names: EVLT, EVLA

Endovenous steam ablation with steam vein sclerosis system.

Procedure

Endovenous steam ablation with steam vein sclerosis.

Other names: SVS, EVSA

Primary outcomes

  1. Obliteration of varicose vein and/ or absence of reflux (>0.5 sec. of retrograde flow over >10cm) along the treated segment of the great saphenous vein (GSV) at 12 and 52 weeks.

    Time frame: 52 weeks

Secondary outcomes

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

    Time frame: 12 weeks

  2. Minor complications: ecchymosis, pain and hyperpigmentation.

    Time frame: 12 weeks

  3. Health related quality of life will be measured using the Dutch Translated Aberdeen Varicose Vein Questionnaire (AVVQ).

    Time frame: 12 weeks

  4. Treatment satisfaction

    Time frame: 2 weeks

  5. Pain score

    Time frame: 2 weeks

  6. Venous Clinical Severity Score (VCSS)

    Time frame: 12 weeks

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Registry information

Official study title

Comparative Randomized Clinical Trial of Steam Ablation Versus Endovenous Laser Ablation for the Treatment of Great Saphenous Veins

Acronym: LAST

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Jan 28, 2014
Registry last updated
Jan 28, 2014

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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