Clinical trial NCT04694287: Volume Flow Assessment to Optimize Angioplasty of Dysfunctional Dialysis Access
Official title: Volume Flow Assessment to Optimize Angioplasty of Dysfunctional Dialysis Access. The VOLA II Multicenter Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dialysis Access Malfunction
Keywords: Percutaneous transluminal angioplasty
Volume-flow measurement
Autologous arteriovenous fistula
Dialysis access
Interventional Radiology
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital of Patras
name: Nefrolgiki SA Hemodialysis Center
First posted: 2021-01-05
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients undergoing fluoroscopically-guided percutaneous balloon angioplasty due to dysfunctional AVF and assessed with pre-and post-procedural volume flow measurements using percutaneous DUS

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Quantification of angioplasty outcome
timeFrame: At the end of the procedure
measure: Correlation between volume flow and clinically-driven reintervention rate
timeFrame: 6 months
Secondary outcomes:
measure: Re-intervention-free rate
timeFrame: 6 months
measure: Identification of independent predictors of reintervention
timeFrame: 6 months
measure: Procedure related complications
timeFrame: 1 week
Other outcomes:
Locations:
city: Patras
country: Greece
facility: Patras Universityu Hospital
state: Achaia
city: Athens
country: Greece
facility: "Attikon" University General Hospital
state: Attiki
city: Athens
country: Greece
facility: Nefrologiki SA Hemodialysis Centre
state: Attiki
Study officials:
References: