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Trial registered on ANZCTR
Registration number
ACTRN12621001134819
Ethics application status
Approved
Date submitted
1/07/2021
Date registered
23/08/2021
Date last updated
24/08/2022
Date data sharing statement initially provided
23/08/2021
Type of registration
Retrospectively registered
Titles & IDs
Public title
The impact of endovascular therapy on clinical, physiological and imaging parameters in patients with ilio-caval occlusive disease
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Scientific title
The impact of endovascular therapy on clinical, physiological and imaging parameters in patients with ilio-caval occlusive disease
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Secondary ID [1]
301835
0
‘Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Ilio-caval venous occlusive disease
318318
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Condition category
Condition code
Cardiovascular
316327
316327
0
0
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Other cardiovascular diseases
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Cardiovascular
320502
320502
0
0
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Diseases of the vasculature and circulation including the lymphatic system
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Intervention/exposure
Study type
Observational
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Patient registry
False
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Observational study of clinical, imaging and physiological parameters for patients undergoing endovascular stenting of the ilio-caval vessels to treat veno-occlusive disease. All procedures will be performed by vascular surgeons. Venography will be performed after access is gained at the groin (via the femoral vein) and/or the neck (via the internal jugular vein). Sheath size will be determined by the type of venous stent used. Venography will be performed using non-ionic contrast media. Pre- and post-treatment venography imaging will be performed and recorded. Intravascular ultrasound (IVUS) will be performed pre- and post-treatment. IVUS measurement of vein size will guide of the size of stents and length of vessels stented. Stents will be deployed under direct fluoroscopic control. Procedural information collected will include the number, size and location of stents deployed and any adverse peri-procedural events. Observations will be performed once prior to treatment and at 3 times over a twelve month period after treatment (one, six and 12 months). The estimated total time for each visit is 1 1/2 hours. Observations will include a blood test for inflammatory markers, assessment of clinical severity (using Clinical, Etiological, Anatomical, and Pathophysiological (CEAP) and Venous Clinical Severity Score (VCSS) tools), quality of life assessment (using VEnous INsufficiency Epidemiological and Economic Study - Quality of Life/Symptoms (VEINES-QOL/Sym) and Euroqol-5D Quality of Life (EQ-5D QoL) tools), duplex and colour Doppler ultrasound assessment of vein anatomy and flow characteristics (including patency and size of the iliac veins, arterial (CFA) and venous (CFV) flow volumes and evidence of venous incompetence), physiological assessment of venous function using air plethysmography (maximum venous outflow and residual volume fraction), bio-impedance body composition analysis, and lower limb volume measurements (using a Perometer). All observations will be performed by vascular surgeons, sonographers, technologists and nurses with at least 5 years experience in the care of patients with vascular disorders. These observations will be performed at a tertiary hospital (Flinders Medical Centre).
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Intervention code [1]
321050
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Diagnosis / Prognosis
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Comparator / control treatment
No control group
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
324495
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Primary patency of treated vein as determined by evidence of antegrade flow through the stented veins using a composite of duplex and colour Doppler ultrasound. Patency will be defined as evidence of flow through the treated vein with both duplex and colour Doppler
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Assessment method [1]
324495
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Timepoint [1]
324495
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1, 6 and 12 months post procedure
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Primary outcome [2]
324496
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Freedom from target vessel re-intervention determined by review of medical records
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Assessment method [2]
324496
0
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Timepoint [2]
324496
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1, 6 and 12 months post procedure
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Secondary outcome [1]
384811
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Changes in clinical severity scores (using a composite of the CEAP and VCSS scores) between baseline and post procedure observations
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Assessment method [1]
384811
0
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Timepoint [1]
384811
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1, 6 and 12 months post procedure
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Secondary outcome [2]
397748
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Changes in venous ulcer severity (if present), based on clinical severity scores (using a composite of the CEAP and VCSS scores), between baseline and post-procedure observations
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Assessment method [2]
397748
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Timepoint [2]
397748
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1, 6 and 12 months post procedure
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Secondary outcome [3]
398624
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Changes in maximum venous outflow (MVO), measured with air-plethysmography, between baseline and post-procedure measurements.
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Assessment method [3]
398624
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Timepoint [3]
398624
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1, 6 and 12 months post procedure
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Secondary outcome [4]
398625
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Changes in fluid content of the lower limbs using bio-impedance body composition analysis between baseline and post-procedure measurements
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Assessment method [4]
398625
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Timepoint [4]
398625
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1, 6 and 12 months post procedure
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Secondary outcome [5]
398626
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Changes in lower limb volume measurement (measure using a Perometer machine,utilising a light emitting diode based method) of both limbs between baseline and post-procedure measurements. This is a composite outcome with volume measurements for the whole limb, thigh and leg being documented.
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Assessment method [5]
398626
0
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Timepoint [5]
398626
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1, 6 and 12 months post procedure
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Secondary outcome [6]
398627
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Degree of stenosis at the time of treatment as defined by IVUS
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Assessment method [6]
398627
0
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Timepoint [6]
398627
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At procedure
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Secondary outcome [7]
398628
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Changes in venous flow volume obtained in the femoral vein using duplex ultrasound between baseline and post-procedure measurements
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Assessment method [7]
398628
0
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Timepoint [7]
398628
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1, 6 and 12 months post procedure
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Secondary outcome [8]
398629
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Changes in severity of venous incompetence, assessed with duplex ultrasound. Venous incompetence is defined as reversed flow in the common femoral vein after flow augmentation (with the severity of reflux being quantified by measurement of the duration of reversed flow) between baseline and post-procedure measurements
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Assessment method [8]
398629
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Timepoint [8]
398629
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1, 6 and 12 months post procedure
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Secondary outcome [9]
399852
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Changes in residual volume fraction (RVF), measured with air-plethysmography, between baseline and post-procedure measurements.
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Assessment method [9]
399852
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Timepoint [9]
399852
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1,3 and 12 months post procedure
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Secondary outcome [10]
399857
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Changes in venous arterial flow index (VAFI), obtained with duplex ultrasound and defined as the ratio of the CFV volume flow divided by the CFA volume flow between baseline and post-procedure measurements
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Assessment method [10]
399857
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Timepoint [10]
399857
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1, 6 and 12 months post procedure
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Eligibility
Key inclusion criteria
Patients with clinical signs and symptoms consistent with the presence of a non-thrombotic iliac vein lesion (NIVL) or post-thrombotic syndrome (PTS)
Clinical condition of sufficient severity that endovascular investigation with potential treatment using iliac venous stenting has been offered.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Patients who are unable to give informed consent due to language difficulties, or physical and/or mental incapacity
Patients under 18 years of age
Allergy to iodine based contrast media
Very short life expectancy (<6 months)
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Study design
Purpose
Natural history
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Duration
Longitudinal
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Selection
Defined population
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Timing
Prospective
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Statistical methods / analysis
Analysis of clinical outcome measures will be performed using Kaplan-Meier survival analysis.
Logistic regression analysis will be used to identify whether there are baseline clinical, physiologic and imaging parameters that are independent predictors of improvement in clinical and quality of life status after treatment.
Relationships between clinical, physiologic and imaging parameters will be investigated using correlation analysis and agreement testing.
Changes between baseline and 12-month results for clinical, physiologic and imaging parameters will be analysed using paired tests of difference.
Validation of clinical severity score will be performed by comparing these scores to imaging and physiological parameters.
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Recruitment
Recruitment status
Stopped early
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Data analysis
No data analysis planned
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Reason for early stopping/withdrawal
Participant recruitment difficulties
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Date of first participant enrolment
Anticipated
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Actual
21/07/2020
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Date of last participant enrolment
Anticipated
22/07/2022
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Actual
20/07/2021
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Date of last data collection
Anticipated
21/07/2023
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Actual
4/02/2022
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Sample size
Target
100
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Accrual to date
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Final
8
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Recruitment in Australia
Recruitment state(s)
SA
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Recruitment hospital [1]
17127
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Flinders Medical Centre - Bedford Park
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Recruitment postcode(s) [1]
30803
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5042 - Bedford Park
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Funding & Sponsors
Funding source category [1]
306260
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Hospital
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Name [1]
306260
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Flinders Medical Centre
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Address [1]
306260
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Flinders Medical Centre
Flinders Drive
Bedford Park 5042
SA
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Country [1]
306260
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Australia
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Primary sponsor type
Hospital
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Name
Flinders Medical Centre
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Address
Flinders Medical Centre
Flinders Drive
Bedford Park 5042
SA
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Country
Australia
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Secondary sponsor category [1]
306748
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None
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Name [1]
306748
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Address [1]
306748
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Country [1]
306748
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
306468
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Southern Adelaide Clinical Human Research Ethics Committee
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Ethics committee address [1]
306468
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Office for Research
Southern Adelaide Local Health Network
Flinders Drive
Bedford Park 5042
SA
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Ethics committee country [1]
306468
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Australia
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Date submitted for ethics approval [1]
306468
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13/05/2020
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Approval date [1]
306468
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26/05/2020
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Ethics approval number [1]
306468
0
96.20
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Summary
Brief summary
The aim of this research is to establish how well stent treatment works at improving the condition of legs affected by narrowing of the veins that drain blood from the leg. It also aims to identify which diagnostic tests are best at determining which veins should be treated.
Although we know that stenting can improve the condition of legs by improving the drainage of blood in legs affected by vein disease it is not clear when stenting should be offered as a treatment. In particular there are few studies that have looked at a wide range of ways of assessing the condition of the legs. There are a range of ways of assessing how severe an area of vein narrowing is, but it is not clear which method is best for guiding the surgeon when deciding whether or not to treat with a stent.
In this research project we will be assessing the condition of the legs using a wide range of methods. We will also assess the narrowing in the vein with a range of different diagnostic tests prior to treatment at the time of the venogram. We will also follow up participants for one year after the treatment to check on the success of the treatment.
From this information we hope to clarify some of the uncertainties around treatment of vein disease by identifying which assessment methods are best for identifying which patients will benefit the most from treatment.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
103994
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Dr Richard Allan
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Address
103994
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Department of Vascular and Endovascular Surgery
Flinders Medical Centre
Flinders Drive
Bedford Park 5042
South Australia
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Country
103994
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Australia
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Phone
103994
0
+61402395505
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Fax
103994
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+61882047106
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Email
103994
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[email protected]
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Contact person for public queries
Name
103995
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Dr Richard Allan
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Address
103995
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Department of Vascular and Endovascular Surgery
Flinders Medical Centre
Flinders Drive
Bedford Park 5042
South Australia
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Country
103995
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Australia
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Phone
103995
0
+61402395505
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Fax
103995
0
+61882047106
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Email
103995
0
[email protected]
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Contact person for scientific queries
Name
103996
0
Dr Richard Allan
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Address
103996
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Department of Vascular and Endovascular Surgery
Flinders Medical Centre
Flinders Drive
Bedford Park 5042
South Australia
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Country
103996
0
Australia
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Phone
103996
0
+61402395505
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Fax
103996
0
+61882047106
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Email
103996
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Currently we do not have ethics committee approval for IPD
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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