Volume Flow Assessment to Optimize Angioplasty of Dysfunctional Dialysis Access

Completed

• Conditions: Dialysis Access Malfunction
• Interventions: Diagnostic Test: Percutaneous DUS volume flow measurements

• Registration Number: NCT04694287
• Lead Sponsor: Attikon Hospital

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.

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2020-12-31
• Study First Submitted QC: 2020-12-31
• Study First Posted: 2021-01-05
• Status Verified: 2023-02
• Primary Completion: 2023-02-15
• Study Completion: 2023-02-15
• Last Update Submitted: 2023-02-18
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Volume flow group	Percutaneous DUS volume flow measurements	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

"Attikon" University General Hospital; 🇬🇷 Athens, Attiki, Greece

Nefrologiki SA Hemodialysis Centre; 🇬🇷 Athens, Attiki, Greece

Patras Universityu Hospital; 🇬🇷 Patras, Achaia, Greece