Intervention for venous stenosis in arteriovenous grafts Urological and Genital Diseases
Conditions
Interventions
This is a multi-site, multi-national, prospective randomized open blinded endpoint (PROBE) trial of the first treatment for a significant VS (> 50%) in patients using an AVG for dialysis.
Pre screeni
Sponsors
NHS Greater Glasgow and Clyde
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Target lesion: 1.1. A significant (>50%) venous stenosis on US or DSA, but confirmed severity prior to intervention using DSA, 1.2. Related to the venous anastomosis (within 8cm), 1.3. That has been determined as requiring intervention, 1.4. Normal outflow vein beyond this with minimum caliber 6mm, 1.5. No previous intervention for venous stenosis or ipsilateral venous stenosis 2. Age =18 at the time of informed consent signature. 3. Capable of complying with protocol requirements, including follow-up. 4. An Informed Consent Form signed by the patient. 5. A previously functioning AVG that has had established normal HD parameters (URR/pressures-flows) for a minimum of 4 weeks. 6. Patient sufficiently fit to withstand maintenance procedures e.g. thrombectomy. 7. No scheduled renal transplant within 60 days. 8. No other outflow tract stenosis, including a normal ipsilateral central venous pathway.
Exclusion criteria
Exclusion criteria: 1. Pregnant female at the time of informed consent signature. 2. AVG implanted less than 4 weeks previously. 3. A plan for conversion to alternative form of renal replacement therapy within 60 days. 4. A history or evidence of severe systemic disease including: 4.1. History of cancer (excludes BCC) with active disease or active anti-tumor (cytotoxic) treatment within the previous year; 4.2. Suspected or documented hyper-coagulable state, unless willing to take anti-coagulation; 4.3. Recurrent (>1/year) unexplained thrombotic episodes; 5. Known or suspected central vein stenosis / occlusion on the side of AVG. 6. Treatment with any investigational drug within 60 days prior to study entry. 7. Any condition that in the judgment of the investigator would preclude adequate evaluation of the trial end points. 8. Unwilling or unable to have regular surveillance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to vascular access abandonment, as measured by the time from procedure to loss of patency of vascular access. This will be measured at 3 monthly intervals (visits 3-8). | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Cost of patient care in each arm will be analysed by a health economist. Healthcare resource use data will be collected by electronic case report form (eCRF) from the trial and supplemented from external routine sources, including Hospital Episode Statistics (England) and equivalent databases for other UK nations where feasible. This will be classified into intervention-related resource use (e.g. medical consumables and medicines utilised, the time required to perform the procedure, intervention medical team composition including relevant NHS bands, length of stay etc.) and access-related/follow-up resource use (e.g. access-related complications and hospitalisations, re-interventions, creation of alternative access, GP/nurse/Allied Health Professional/outpatient visits, ambulance attendance, A&E attendance, inpatient admissions, critical care stay). Adverse events related to the intervention that result in resource utilisation will also be recorded and included in the analysis. This will be calculated for the duration the patient is in the trial. 2. Quality of life measured by VAS-QoL and EQ-5D at screening and 3 monthly at visits 3-8 3. Patency of treatment measured by the medical opinion of the staff attempting to use the vascular access for dialysis treatment. After this procedure this will be measured 3 monthly at visits 3-8. 4. Time to re-intervention from randomisation. The treating clinician will decide if reintervention is necessary based on clinical opinion. This will be measured from randomisationuntil re-intervention is needed. | — |
Countries
England, Greece, Italy, Scotland, United Kingdom, Wales
Outcome results
None listed