NCT02046967

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
237

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2009

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

January 23, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 28, 2014

Completed
Last Updated

January 28, 2014

Status Verified

January 1, 2014

Enrollment Period

3.3 years

First QC Date

January 23, 2014

Last Update Submit

January 27, 2014

Conditions

Varicose VeinsVaricose Veins of Leg With Long Saphenous Vein Distribution

Keywords

endovenous laser ablationendovenous steam ablationgreat saphenous veinsquality of life

Outcome Measures

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.

    52 weeks

Secondary Outcomes (6)

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

    12 weeks

  • Minor complications: ecchymosis, pain and hyperpigmentation.

    12 weeks

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

    12 weeks

  • Treatment satisfaction

    2 weeks

  • Pain score

    2 weeks

  • +1 more secondary outcomes

Study Arms (2)

Endovenous laser ablation

ACTIVE COMPARATOR

Endovenous laser ablation with 940 nm bare fiber.

Procedure: Endovenous laser ablation with 940 nm bare fiber

Endovenous steam ablation

ACTIVE COMPARATOR

Endovenous steam ablation with steam vein sclerosis system.

Procedure: Endovenous steam ablation with steam vein sclerosis system.

Interventions

Endovenous laser ablation with 940 nm bare fiberPROCEDURE

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

Also known as: EVLT, EVLA
Endovenous laser ablation
Endovenous steam ablation with steam vein sclerosis system.PROCEDURE

Endovenous steam ablation with steam vein sclerosis.

Also known as: SVS, EVSA
Endovenous steam ablation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Erasmus MC

Rotterdam, 3015 CA, Netherlands

Location

Related Publications (1)

  • 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.

    PMID: 24981585DERIVED

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Renate R van den Bos, MD, PhD

    Erasmus Medical Center

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

January 23, 2014

First Posted

January 28, 2014

Study Start

November 1, 2009

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

January 28, 2014

Record last verified: 2014-01

Locations

NL(1)