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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
Scientific title
The impact of endovascular therapy on clinical, physiological and imaging parameters in patients with ilio-caval occlusive disease
Secondary ID [1] 301835 0
‘Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Ilio-caval venous occlusive disease 318318 0
Condition category
Condition code
Cardiovascular 316327 316327 0 0
Other cardiovascular diseases
Cardiovascular 320502 320502 0 0
Diseases of the vasculature and circulation including the lymphatic system

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
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).
Intervention code [1] 321050 0
Diagnosis / Prognosis
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 324495 0
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
Timepoint [1] 324495 0
1, 6 and 12 months post procedure
Primary outcome [2] 324496 0
Freedom from target vessel re-intervention determined by review of medical records
Timepoint [2] 324496 0
1, 6 and 12 months post procedure
Secondary outcome [1] 384811 0
Changes in clinical severity scores (using a composite of the CEAP and VCSS scores) between baseline and post procedure observations
Timepoint [1] 384811 0
1, 6 and 12 months post procedure
Secondary outcome [2] 397748 0
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
Timepoint [2] 397748 0
1, 6 and 12 months post procedure
Secondary outcome [3] 398624 0
Changes in maximum venous outflow (MVO), measured with air-plethysmography, between baseline and post-procedure measurements.
Timepoint [3] 398624 0
1, 6 and 12 months post procedure
Secondary outcome [4] 398625 0
Changes in fluid content of the lower limbs using bio-impedance body composition analysis between baseline and post-procedure measurements
Timepoint [4] 398625 0
1, 6 and 12 months post procedure
Secondary outcome [5] 398626 0
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.
Timepoint [5] 398626 0
1, 6 and 12 months post procedure
Secondary outcome [6] 398627 0
Degree of stenosis at the time of treatment as defined by IVUS
Timepoint [6] 398627 0
At procedure
Secondary outcome [7] 398628 0
Changes in venous flow volume obtained in the femoral vein using duplex ultrasound between baseline and post-procedure measurements
Timepoint [7] 398628 0
1, 6 and 12 months post procedure
Secondary outcome [8] 398629 0
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
Timepoint [8] 398629 0
1, 6 and 12 months post procedure
Secondary outcome [9] 399852 0
Changes in residual volume fraction (RVF), measured with air-plethysmography, between baseline and post-procedure measurements.
Timepoint [9] 399852 0
1,3 and 12 months post procedure
Secondary outcome [10] 399857 0
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
Timepoint [10] 399857 0
1, 6 and 12 months post procedure

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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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)

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
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.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
21/07/2020
Date of last participant enrolment
Anticipated
22/07/2022
Actual
20/07/2021
Date of last data collection
Anticipated
21/07/2023
Actual
4/02/2022
Sample size
Target
100
Accrual to date
Final
8
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 17127 0
Flinders Medical Centre - Bedford Park
Recruitment postcode(s) [1] 30803 0
5042 - Bedford Park

Funding & Sponsors
Funding source category [1] 306260 0
Hospital
Name [1] 306260 0
Flinders Medical Centre
Country [1] 306260 0
Australia
Primary sponsor type
Hospital
Name
Flinders Medical Centre
Address
Flinders Medical Centre
Flinders Drive
Bedford Park 5042
SA
Country
Australia
Secondary sponsor category [1] 306748 0
None
Name [1] 306748 0
Address [1] 306748 0
Country [1] 306748 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 306468 0
Southern Adelaide Clinical Human Research Ethics Committee
Ethics committee address [1] 306468 0
Ethics committee country [1] 306468 0
Australia
Date submitted for ethics approval [1] 306468 0
13/05/2020
Approval date [1] 306468 0
26/05/2020
Ethics approval number [1] 306468 0
96.20

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 103994 0
Dr Richard Allan
Address 103994 0
Department of Vascular and Endovascular Surgery
Flinders Medical Centre
Flinders Drive
Bedford Park 5042
South Australia
Country 103994 0
Australia
Phone 103994 0
+61402395505
Fax 103994 0
+61882047106
Email 103994 0
richard.allan@sa.gov.au
Contact person for public queries
Name 103995 0
Richard Allan
Address 103995 0
Department of Vascular and Endovascular Surgery
Flinders Medical Centre
Flinders Drive
Bedford Park 5042
South Australia
Country 103995 0
Australia
Phone 103995 0
+61402395505
Fax 103995 0
+61882047106
Email 103995 0
richard.allan@sa.gov.au
Contact person for scientific queries
Name 103996 0
Richard Allan
Address 103996 0
Department of Vascular and Endovascular Surgery
Flinders Medical Centre
Flinders Drive
Bedford Park 5042
South Australia
Country 103996 0
Australia
Phone 103996 0
+61402395505
Fax 103996 0
+61882047106
Email 103996 0
richard.allan@sa.gov.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Currently we do not have ethics committee approval for IPD


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.