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

Primary Purpose

Varicose Veins, Varicose Veins of Leg With Long Saphenous Vein Distribution

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Endovenous laser ablation with 940 nm bare fiber
Endovenous steam ablation with steam vein sclerosis system.
Sponsored by
Erasmus Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Varicose Veins focused on measuring endovenous laser ablation, endovenous steam ablation, great saphenous veins, quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Erasmus MC

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Endovenous laser ablation

Endovenous steam ablation

Arm Description

Endovenous laser ablation with 940 nm bare fiber.

Endovenous steam ablation with steam vein sclerosis system.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Major complications: deep and superficial venous thrombosis (embolic events), nerve injury, skin burns, and (sub)cutaneous infections.
Minor complications: ecchymosis, pain and hyperpigmentation.
Health related quality of life will be measured using the Dutch Translated Aberdeen Varicose Vein Questionnaire (AVVQ).
Treatment satisfaction
Pain score
Venous Clinical Severity Score (VCSS)

Full Information

First Posted
January 23, 2014
Last Updated
January 27, 2014
Sponsor
Erasmus Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02046967
Brief Title
Steam Ablation Versus Endovenous Laser Ablation for the Treatment of Great Saphenous Veins
Acronym
LAST
Official Title
Comparative Randomized Clinical Trial of Steam Ablation Versus Endovenous Laser Ablation for the Treatment of Great Saphenous Veins
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
March 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Erasmus Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Varicose Veins, Varicose Veins of Leg With Long Saphenous Vein Distribution
Keywords
endovenous laser ablation, endovenous steam ablation, great saphenous veins, quality of life

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
237 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Endovenous laser ablation
Arm Type
Active Comparator
Arm Description
Endovenous laser ablation with 940 nm bare fiber.
Arm Title
Endovenous steam ablation
Arm Type
Active Comparator
Arm Description
Endovenous steam ablation with steam vein sclerosis system.
Intervention Type
Procedure
Intervention Name(s)
Endovenous laser ablation with 940 nm bare fiber
Other Intervention Name(s)
EVLT, EVLA
Intervention Description
Endovenous laser ablation with 940 nm Diode laser using a bare fiber for treating the Great Saphenous Vein.
Intervention Type
Procedure
Intervention Name(s)
Endovenous steam ablation with steam vein sclerosis system.
Other Intervention Name(s)
SVS, EVSA
Intervention Description
Endovenous steam ablation with steam vein sclerosis.
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Major complications: deep and superficial venous thrombosis (embolic events), nerve injury, skin burns, and (sub)cutaneous infections.
Time Frame
12 weeks
Title
Minor complications: ecchymosis, pain and hyperpigmentation.
Time Frame
12 weeks
Title
Health related quality of life will be measured using the Dutch Translated Aberdeen Varicose Vein Questionnaire (AVVQ).
Time Frame
12 weeks
Title
Treatment satisfaction
Time Frame
2 weeks
Title
Pain score
Time Frame
2 weeks
Title
Venous Clinical Severity Score (VCSS)
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Renate R van den Bos, MD, PhD
Organizational Affiliation
Erasmus Medical Center
Official's Role
Study Director
Facility Information:
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3015 CA
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
24981585
Citation
van den Bos RR, Malskat WS, De Maeseneer MG, de Roos KP, Groeneweg DA, Kockaert MA, Neumann HA, Nijsten T. Randomized clinical trial of endovenous laser ablation versus steam ablation (LAST trial) for great saphenous varicose veins. Br J Surg. 2014 Aug;101(9):1077-83. doi: 10.1002/bjs.9580. Epub 2014 Jun 30. Erratum In: Br J Surg. 2014 Oct;101(11):1484.
Results Reference
derived

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

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