Dialysis Access Malfunction
Conditions
Keywords
Percutaneous transluminal angioplasty, Volume-flow measurement, Autologous arteriovenous fistula, Dialysis access, Interventional Radiology
Brief summary
This is a multicenter, prospective study investigating a new concept of intra-procedural percutaneous duplex ultrasound (DUS) volume flow-guided balloon angioplasty for the quantification and optimization of endovascular treatment outcomes of dysfunctional autologous arteriovenous fistulae (AVF).
Detailed description
This is a prospective, multi-center, single-arm observational clinical trial investigating a new functional index of success of endovascular treatment of dysfunctional AVF assessed with intraprocedural percutaneous DUS. The study will include 100 consecutive patients undergoing fluoroscopically-guided percutaneous balloon angioplasty due to dysfunctional AVF. Exclusion criteria will be (i) patients with arteriovenous synthetic grafts. (ii) Immature AFVs not previously used for hemodialysis (at least once). Patients' demographical data, dialysis access history, and procedural details will be recorded. Intraprocedural volume flow measurements will be obtained just prior to the procedure and after final balloon dilation, before sheath removal. Clinical follow-up will be set at 6 months after the index procedure. All DUS measurements will be performed using the same imaging protocol. The study's primary endpoints will be (i) the quantification of angioplasty outcome using DUS volume flow analysis before sheath insertion and at the end of the procedure before sheath removal and (ii) to assess the correlation between volume flow at the end of the procedure and clinically driven re-intervention-free rate at defined as the rate of reintervention due to dysfunction recurrence of the treated AVF. Secondary endpoints will be (i) to assess the correlation between volume flow and clinical success defined as high-quality dialysis for a period of at least one month and (ii) identification of independent predictors of re-intervention-free rate.
Interventions
DIAGNOSTIC_TESTPercutaneous DUS volume flow measurements
Volume flow measurements of the AFV will be obtained using intraprocedural DUS just prior to sheath insertion and at the end of the final balloon dilation, before sheath removal.
Sponsors
University Hospital of Patras
Nefrolgiki SA Hemodialysis Center
Attikon Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Consecutive patients undergoing fluoroscopically-guided percutaneous balloon angioplasty due to dysfunctional AVF * Signed consent form * Agree to the study protocol
Exclusion criteria
* Patients with arteriovenous synthetic grafts * Patients with contraindication to antiplatelet therapy * Immature AFVs, not previously used for at least one dialysis session.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Quantification of angioplasty outcome | At the end of the procedure | The quantification of angioplasty outcomes will be performed using DUS volume flow analysis |
| Correlation between volume flow and clinically-driven reintervention rate | 6 months | The investigators will use ROC analysis to define cut off values of volume flow at the end of the procedure to predict clinically-driven reintervention rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Re-intervention-free rate | 6 months | The clinically driven re-intervention-free rate due to dysfunction recurrence of the treated AVF following endovascular treatment |
| Identification of independent predictors of reintervention | 6 months | Multivariable analysis will be performed to identify independent predictors of reintervention-free rate |
| Procedure related complications | 1 week | Minor and major procedure related complications will be recorded |
Countries
Greece
Outcome results
None listed