NCT02010723

Brief Summary

The purpose of this study is to compare two therapeutic procedures in the treatment of isolated varicosis of the anterior accessory great saphenous vein (AAGSV): crossectomy and avulsion of the varicose AAGSV versus foam sclerotherapy of the AAGSV.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jun 2006

Longer than P75 for phase_4

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

June 1, 2006

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

November 18, 2013

Completed
25 days until next milestone

First Posted

Study publicly available on registry

December 13, 2013

Completed
Last Updated

December 13, 2013

Status Verified

December 1, 2013

Enrollment Period

5.7 years

First QC Date

November 18, 2013

Last Update Submit

December 12, 2013

Conditions

Varicose Veins

Keywords

varicosisfoam sclerotherapysurgery

Outcome Measures

Primary Outcomes (1)

  • duplex-sonographic recurrence after 3 years

    duplex-sonographic recurrence is defined as reverse blood flow of \> 0.5 sec along the anterior accessory great saphenous vein (AAGSV) in the sclerotherapy group or in new anterior thigh varicosities connected to the previous saphenofemoral junction (NATV) in the surgical group.

    3 years

Secondary Outcomes (3)

  • duplex-sonographic recurrence after 1 year

    1 year

  • clinical recurrence

    1 year and 3 years

  • neovascularisation in the saphenofemoral junction

    1 year and 3 years

Study Arms (2)

surgery

ACTIVE COMPARATOR

crossectomy and avulsion of the varicose anterior accessory great saphenous vein (AAGSV) under local anesthesia

Procedure: surgery

sclerotherapy

EXPERIMENTAL

foam sclerotherapy with aethoxysclerol foam

Drug: sclerotherapy with aethoxysclerol foam

Interventions

surgeryPROCEDURE

crossectomy and avulsion of the varicose anterior accessory great saphenous vein (AAGSV) under local anesthesia

surgery
sclerotherapy with aethoxysclerol foamDRUG

foam sclerotherapy with aethoxysclerol foam

sclerotherapy

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • reflux in anterior accessory great saphenous vein (AAGSV) \> 0,5 sek

You may not qualify if:

  • concomitant reflux in great saphenous vein (GSV)
  • reflux in the deep venous system (postthrombotic syndrome)
  • acute thrombosis
  • hypercoagulability
  • allergy to aethoxysclerol or local anesthetics
  • immobility
  • open foramen ovale
  • bacterial infection of the skin
  • pregnancy and breast feeding
  • peripheral arterial occlusive disease III, IV (PAOD)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University of Vienna, Department of General Dermatology

Vienna, Vienna, 1090, Austria

Location

Related Publications (3)

  • Prinz N, Selzle K, Kamionek I, Sagoo KS, Leberig A, Kaiser R, Schonath M. [Surgery of the lateral accessory saphenous vein]. Zentralbl Chir. 2001 Jul;126(7):526-7. doi: 10.1055/s-2001-16280. German.

    PMID: 11503465BACKGROUND

  • Breu FX, Guggenbichler S, Wollmann JC; Second European Consensus Meeting on Foam Sclerotherapy. Duplex ultrasound and efficacy criteria in foam sclerotherapy from the 2nd European Consensus Meeting on Foam Sclerotherapy 2006, Tegernsee, Germany. Vasa. 2008 Feb;37(1):90-5. doi: 10.1024/0301-1526.37.1.90.

    PMID: 18512547BACKGROUND

  • Theivacumar NS, Darwood RJ, Gough MJ. Endovenous laser ablation (EVLA) of the anterior accessory great saphenous vein (AAGSV): abolition of sapheno-femoral reflux with preservation of the great saphenous vein. Eur J Vasc Endovasc Surg. 2009 Apr;37(4):477-81. doi: 10.1016/j.ejvs.2008.11.035. Epub 2009 Feb 7.

    PMID: 19201621BACKGROUND

MeSH Terms

Conditions

Varicose Veins

Interventions

Surgical Procedures, OperativeSclerotherapy

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Kornelia Boehler, MD

    Medical University of Vienna, University Clinic of Dermatology, Department of General Dermatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

November 18, 2013

First Posted

December 13, 2013

Study Start

June 1, 2006

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

December 13, 2013

Record last verified: 2013-12

Locations

AU(1)