Volume Flow Assessment to Optimize Angioplasty of Dysfunctional Dialysis Access (VOLAII)

Volume Flow Assessment to Optimize Angioplasty of Dysfunctional Dialysis Access. The VOLA II Multicenter Study

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).

Study Overview

• Status: Completed
• Conditions: Dialysis Access Malfunction
• Intervention / Treatment: Diagnostic test: Percutaneous DUS volume flow measurements

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.

• Study Type: Observational
• Enrollment (Actual): 100

Contacts and Locations

Study Locations

• Greece
  • Achaia
    • Patras, Achaia, Greece
      • Patras Universityu Hospital
  • Attiki
    • Athens, Attiki, Greece, 12461
      • "ATTIKON" University General Hospital
    • Athens, Attiki, Greece
      • Nefrologiki SA Hemodialysis Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Volume flow group; The study will include consecutive patients undergoing standard fluoroscopically-guided percutaneous balloon angioplasty due to dysfunctional AVF. Intraprocedural volume flow measurements will be obtained just prior to the procedure and after final balloon dilation.	Diagnostic test: Percutaneous 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quantification of angioplasty outcome	The quantification of angioplasty outcomes will be performed using DUS volume flow analysis	At the end of the procedure
Correlation between volume flow and clinically-driven reintervention rate	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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-intervention-free rate	The clinically driven re-intervention-free rate due to dysfunction recurrence of the treated AVF following endovascular treatment	6 months
Identification of independent predictors of reintervention	Multivariable analysis will be performed to identify independent predictors of reintervention-free rate	6 months
Procedure related complications	Minor and major procedure related complications will be recorded	1 week

Collaborators and Investigators

• Sponsor: Attikon Hospital
• Collaborators: University Hospital of Patras; Nefrolgiki SA Hemodialysis Center

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): February 15, 2023
• Study Completion (Actual): February 15, 2023

Study Registration Dates

• First Submitted: December 31, 2020
• First Submitted That Met QC Criteria: December 31, 2020
• First Posted (Actual): January 5, 2021

Study Record Updates

• Last Update Posted (Estimate): February 21, 2023
• Last Update Submitted That Met QC Criteria: February 18, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Interventional Radiology; Dialysis access; Percutaneous transluminal angioplasty; Autologous arteriovenous fistula; Volume-flow measurement
• Other Study ID Numbers: EBD 692

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Available after study publication, upon reasonable request
• IPD Sharing Time Frame: Starting 1 month after publication and for 2 years
• IPD Sharing Access Criteria: Reasonable request (systematic review, metaanalysis)
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No