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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02046967
Recruitment Status : Completed
First Posted : January 28, 2014
Last Update Posted : January 28, 2014
Sponsor:
Information provided by (Responsible Party):
RR van den Bos, Erasmus Medical Center

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Varicose Veins Varicose Veins of Leg With Long Saphenous Vein Distribution Procedure: Endovenous laser ablation with 940 nm bare fiber Procedure: Endovenous steam ablation with steam vein sclerosis system. Not Applicable

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 237 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Comparative Randomized Clinical Trial of Steam Ablation Versus Endovenous Laser Ablation for the Treatment of Great Saphenous Veins
Study Start Date : November 2009
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Varicose Veins

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Endovenous laser ablation
Endovenous laser ablation with 940 nm bare fiber.
 Procedure: Endovenous laser ablation with 940 nm bare fiber
Endovenous laser ablation with 940 nm Diode laser using a bare fiber for treating the Great Saphenous Vein.
Other Names:
  • EVLT
  • EVLA
Active Comparator: Endovenous steam ablation
Endovenous steam ablation with steam vein sclerosis system.
 Procedure: Endovenous steam ablation with steam vein sclerosis system.
Endovenous steam ablation with steam vein sclerosis.
Other Names:
  • SVS
  • EVSA


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02046967


Locations
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Netherlands
Erasmus MC
Rotterdam, Netherlands, 3015 CA
Sponsors and Collaborators
Erasmus Medical Center
Investigators
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Study Director: Renate R van den Bos, MD, PhD Erasmus Medical Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: RR van den Bos, MD, PhD, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT02046967    
Other Study ID Numbers: ErasmusMC
First Posted: January 28, 2014    Key Record Dates
Last Update Posted: January 28, 2014
Last Verified: January 2014
Keywords provided by RR van den Bos, Erasmus Medical Center:
endovenous laser ablation
endovenous steam ablation
great saphenous veins
quality of life
Additional relevant MeSH terms:
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Varicose Veins
Vascular Diseases
Cardiovascular Diseases