Arteriovenous Fistula, Fistula
Conditions
Keywords
Angioplasty, cutting balloon
Brief summary
The main objective of this study is to evaluate and compare the primary patency rate at 12 months in a group of hemodialysis patients operated on by cutting balloon and in a group of hemodialysis patients operated by conventional balloon.
Interventions
PROCEDURECutting balloon angioplasty
Angioplasty of fistula stenosis using a cutting balloon
PROCEDUREAngioplasty
Angioplasty of fistula stenosis using a non-cutting balloon
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* The patient must have given his/her informed and signed consent * The patient must be insured or beneficiary of a health insurance plan * The patient is available for 12 months of follow-up * The patient is on hemodialysis because of chronic renal insufficiency * The patient's vascular access is an arterio-venous fistula * The patient has a venous stenosis in the fistula (first event in the studied zone) * The patient is scheduled for angioplasty
Exclusion criteria
* The patient is participating in another study * The patient is in an exclusion period determined by a previous study * The patient is under judicial protection, under tutorship or curatorship * The patient refuses to sign the consent * It is impossible to correctly inform the patient * The patient cannot fluently read French * The patient cannot understand French * The patient is pregnant * The patient is breastfeeding * Short term dialysis * The vascular access is a graft * The stenosis in question is a recurrence, and not a first event in the studied zone * The life expectancy of the patient is \< 12 months * Medical emergency situation * Peritoneal dialysis * At-home dialysis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary patency | 12 months | Primary patency following a first angioplasty of a first stenose in the affected zone. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of re-stenoses | 12 months | Stenosis defined as lumen diameter \< 2mm |
| Total days in hospital | 12 months | The total number of days hospitalized for stenosis, thrombosis, or recovering vascular access. This does not include regular hemodialysis activities. |
| Number of stents used | 12 months | The total number of stents placed between the study angioplasty and the end-of-study visit. |
| Total number of venous thromboses | 12 months | Total number of venous thromboses between study angioplasty and end-of-study visit |
| Direct medical costs (€) | 12 months | — |
| Indirect costs (€) | 12 months | — |
| Number of early re-stenoses | 3 months | stenosis defined as lumen diameter \< 2mm |
| Questionnaire SF36 | 12 months | — |
| Fistula quality (cm*ml/min) | Baseline | cumulative length of usable fistula (cm) \* venous flow during the last hemodialysis (ml/min) |
| % Stenosis | Baseline | 100-((the smallest diameter of the stenosis lumen (mm)/ the diameter of a proximal, normal portion of lumen (mm))\*100) |
| Presence/absence of complications associated with the angioplasty | Day of intervention | — |
| Presence/absence of complications since the last visit | 6 months | — |
| Questionnaire KDQOL | 12 months | — |
Countries
France
Outcome results
None listed