None listed
Conditions
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.
Interventions
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- an
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).
Sponsors
Flinders Medical Centre
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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.
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)
Outcome results
None listed