Pelvic Embolisation to Reduce Recurrent Varicose Veins - Recurrent
A Randomised Controlled Trial Investigating The Use Of Pelvic Vein Embolisation To Reduce Recurrent Varicose Veins Of The Legs In Women With Recurrent Varicose Veins And Associated Pelvic Venous Reflux.
1 other identifier
interventional
270
1 country
2
Brief Summary
The aim of this study is to identify whether the treatment of pelvic venous reflux (pelvic embolisation) in females with recurrent leg varicose veins, who have a proven contribution to their leg varicose veins from pelvic venous reflux, have a reduction in future recurrence after endovenous laser treatment for recurrent varicose veins in the legs.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jul 2013
Longer than P75 for not_applicable
2 active sites
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
Study Start
First participant enrolled
July 1, 2013
CompletedFirst Submitted
Initial submission to the registry
July 2, 2013
CompletedFirst Posted
Study publicly available on registry
July 26, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2018
CompletedMay 19, 2014
May 1, 2014
5.3 years
July 2, 2013
May 16, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in recurrent varicose veins or venus reflux
Does the patient have recurrence? Recurrent varicose veins will be divided into: * Clinically insignificant (thread veins, reticular veins or varicose veins less than 3 mm in diameter) * Significant (varicose veins greater than 3 mm in diameter, varicose veins associated with thrombophlebitis, or skin changes such as venous eczema, red skin or Brown skin overlying the veins)
6 weeks, 6 months, 1 year, 2 years, 3 years, 4 years and 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
EXPERIMENTALtransjugular coil embolisation of pelvic veins followed by endovenous treatment of leg recurrent varicose veins
endovenous treatment of leg recurrent varicose veins alone
ACTIVE COMPARATORendovenous treatment of leg recurrent varicose veins alone
Interventions
transjugular coil embolisation of pelvic veins
endovenous treatment of leg recurrent varicose veins
Eligibility Criteria
You may qualify if:
- Females presenting with recurrent varicose veins in one or both legs with ultrasound proven pelvic venous reflux in at least one pelvic venous trunk communicating with the leg varicose veins
- Duplex proven reflux in the superficial venous system of the leg
- Over 18 years old
- Able to understand and give consent
- Willing to attend for follow-up over the five years
You may not qualify if:
- Pelvic venous 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 within the next five years
- Under 18 years of age
- Unable to understand all give consent
- Any vascular malformation of the pelvis all the 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
The Imaging Clinic
Guildford, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Whiteley, Professor
The Whiteley Clinic
Central Study Contacts
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 26, 2013
Study Start
July 1, 2013
Primary Completion
October 1, 2018
Study Completion
December 1, 2018
Last Updated
May 19, 2014
Record last verified: 2014-05