Volume Flow-guided Angioplasty of Dysfunctional Dialysis Access (VOLA)

VOLume Flow-guided Angioplasty of Dysfunctional Autologous Arteriovenous Fistula. The VOLA Pilot Study

This is a pilot 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: Volume flow guided angioplasty

Detailed Description

This is a prospective, single-center, single-arm clinical trial introducing a new functional index of clinical success of endovascular treatment and investigating the feasibility of volume flow-guided balloon angioplasty of dysfunctional AVF assessed with intraprocedural percutaneous DUS. The study will include consecutive patients undergoing fluoroscopically-guided percutaneous balloon angioplasty due to dysfunctional AVF in the investigator's center. Exclusion criteria will be: (i) not available volume flow values at the time of AVF maturation, (ii) patients with arteriovenous synthetic grafts. 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 each balloon dilation. Volume flow measurements will be correlated with digital subtraction angiography quantitative vessel analysis (QVA) performed by an independent investigator blinded to the volume flow analysis outcomes. Follow up DUS imaging including volume-flow assessment will be set at 24h, 6, and 12 months after the index procedure, while fistulograms with QVA analysis will be performed at 6 and 12 months. All DUS measurements will be performed using the same imaging protocol and the same operator. The study's primary endpoints will be (i) the quantification of angioplasty outcome using sequential DUS volume flow analysis following each balloon catheter dilation and (ii) to assess the correlation between volume flow and clinical success defined as high-quality dialysis for a period of at least one month. Secondary endpoints will be (i) re-intervention-free interval defined as the time interval between endovascular treatment and reintervention due to dysfunction recurrence of the treated AVF and (ii) correlation between volume flow and QVA measurements.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Greece
  • Attiki
    • Athens, Attiki, Greece, 12461
      • "ATTIKON" University General Hospital
    • Athens, Attiki, Greece
      • Medifil SA Hemodialysis Centre
    • Athens, Attiki, Greece
      • Nefrologiki SA Hemodialysis Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Consecutive patients undergoing fluoroscopically-guided percutaneous balloon angioplasty due to dysfunctional AVF
• Signed consent form
• Agree to the imaging protocol

Exclusion Criteria:

• not available volume flow values at the time of AVF maturation
• patients with arteriovenous synthetic grafts.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Volume flow group; Consecutive patients undergoing sequential volume flow measurements using percutaneous DUS	Diagnostic test: Volume flow guided angioplasty; Volume flow measurements using DUS will be obtained at the end of each balloon dilation, at 24 hours, 6 months, and one year after index procedure.

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 sequential DUS volume flow analysis	At the end of the procedure
Duplex Ultrasound volume flow values achieved following angioplasty and clinical success	The investigators will use ROC analysis to define a cut off value of volume flow increase (ml per minute) at the end of the procedure to predict clinical success.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Re-intervention-free interval	The time interval between endovascular treatment and reintervention due to dysfunction recurrence of the treated AVF	6 months
Comparison of Duplex Ultrasound volume flow values with digital subtraction angiography QVA measurements.	To assess wheather a significant volume flow decrease of >50% measured by Duplex ultrasound indicates an analougously significant late lumen loss (mm) of the target lesion measured with QVA analysis of digital subtracted venography	6 months

Collaborators and Investigators

• Sponsor: Attikon Hospital
• Investigators: Principal Investigator: Stavros Spiliopoulos, MD, PhD, EBIR, ATTIKO University Hospital

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 10, 2019
• Primary Completion (ACTUAL): December 21, 2020
• Study Completion (ACTUAL): December 21, 2020

Study Registration Dates

• First Submitted: June 10, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (ACTUAL): June 12, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 22, 2020
• Last Update Submitted That Met QC Criteria: December 21, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: Dialysis access; Percutaneous transluminal angioplasty; Volume-flow measurment; Autologous arteriovenous fistula
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Congenital Abnormalities; Pathological Conditions, Anatomical; Cardiovascular Abnormalities; Vascular Malformations; Arteriovenous Malformations; Vascular Fistula; Fistula; Arteriovenous Fistula
• Other Study ID Numbers: 323

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The investigators plan to make individual participant data (IPD) available to other researchers upon request.
• IPD Sharing Time Frame: After the publication of the study, indefinitely
• IPD Sharing Access Criteria: Other researchers upon request
• 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