NCT01901731

Brief Summary

The aim of this study is to identify whether the treatment of pelvic venous reflux (pelvic coil embolisaton) in females with leg varicose veins, who have a proven contribution to their leg varicose veins from pelvic reflux, have a reduction in recurrence after varicose vein surgery.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
270

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 2, 2013

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 17, 2013

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2018

Completed
Last Updated

January 27, 2014

Status Verified

January 1, 2014

Enrollment Period

4.5 years

First QC Date

July 2, 2013

Last Update Submit

January 24, 2014

Conditions

Varicose VeinsVenous Reflux

Keywords

transjugular coil embolisationendovenous treatment of varicose veinspelvic venous refluxrecurrent varicose veins

Outcome Measures

Primary Outcomes (1)

  • Change in recurrent varicose veins or venous reflux

    Recurrent varicose veins or venous reflux shown on duplex ultrasonography to be arising from pelvic venous reflux. Recurrent varicose veins will be divided into : Clinically insignificant (thread veins, reticular veins or varicose veins less than 3mm in diameter) Significant (varicose veins greater then 3mm in diameter, varicose veins associated with thrombophlebitis, or skin changes such as eczema, red skin or brown skin overlying the veins)

    6 weeks post surgery, 6 months post surgery, 1 year post surgery, 2 years post surgery, 3 years post surgery, 4 years post surgery, 5 years post surgery

Secondary Outcomes (4)

  • Quality of life

    6 weeks post surgery, 6 months post surgery, 1 year post surgery, 2 years post surgery, 3 years post surgery, 4 years post surgery, 5 years post surgery

  • Patient satisfaction

    6 weeks post surgery, 6 months post surgery, 1 year post surgery, 2 years post surgery, 3 years post surgery, 4 years post surgery, 5 years post surgery

  • Symptom severity

    6 weeks post surgery, 6 months post surgery, 1 year post surgery, 2 years post surgery, 3 years post surgery, 4 years post surgery, 5 years post surgery

  • Source of recurrence

    6 weeks post surgery, 6 months post surgery, 1 year post surgery, 2 years post surgery, 3 years post surgery, 4 years post surgery, 5 years post surgery

Other Outcomes (1)

  • Adverse events

    6 weeks post surgery, 6 months post surgery, 1 year post surgery, 2 years post surgery, 3 years post surgery, 4 years post surgery, 5 years post surgery

Study Arms (2)

Embolisation of pelvic veins & treatment of leg varicose veins

EXPERIMENTAL

Transjugular coil embolisation of pelvic veins followed by endovenous treatment of leg varicose veins

Procedure: transjugular coil embolisation of pelvic veinsProcedure: endovenous treatment of leg varicose veins

Endovenous treatment of leg varicose veins alone

ACTIVE COMPARATOR

Endovenous treatment of legs varicose veins only

Procedure: endovenous treatment of leg varicose veins

Interventions

transjugular coil embolisation of pelvic veinsPROCEDURE
Embolisation of pelvic veins & treatment of leg varicose veins
endovenous treatment of leg varicose veinsPROCEDURE
Embolisation of pelvic veins & treatment of leg varicose veinsEndovenous treatment of leg varicose veins alone

Eligibility Criteria

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

You may qualify if:

  • Female gender
  • Presenting with primary varicose veins in one or both legs with ultrasound --pelvic venous reflux in at least one trunk communicating with the leg varicose veins
  • Over 18 years old
  • Able to understand and give consent
  • Willing to attend for follow ups over five year period

You may not qualify if:

  • Pelvic reflux does not communicate with the varicose veins to be treated in the legs
  • If pelvic venous reflux communicates and contributes to varicose veins in one leg, but not the other, only the leg with a pelvic venous contribution will be entered into the study.
  • Currently pregnant or plans for pregnancy in the next five years
  • Under 18 years of age.
  • Unable to understand or give consent.
  • Any vascular malformation of the pelvis or legs, apart from that diagnosed as venous reflux disease.
  • Any medical condition likely to cause death or serious ill health within the next five years.
  • Any deep venous obstruction or reflux.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

The Whiteley Clinic

Guildford, GU2 7RF, United Kingdom

Location

The Imaging Clinic

Guildford, United Kingdom

Location

MeSH Terms

Conditions

Varicose Veins

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Mark Whiteley, Professor

    The Whiteley Clinic

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Briony Hudson

CONTACT

01483 477180bh00047@surrey.ac.uk

Isabel Kay

CONTACT

01483 477180isabel@thewhiteleyclinic.co.uk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2013

First Posted

July 17, 2013

Study Start

March 1, 2014

Primary Completion

September 1, 2018

Study Completion

October 1, 2018

Last Updated

January 27, 2014

Record last verified: 2014-01

Locations

GB(2)