NCT04694287

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2020

Typical duration for all trials

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 31, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 5, 2021

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 15, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 15, 2023

Completed
Last Updated

February 21, 2023

Status Verified

February 1, 2023

Enrollment Period

2.7 years

First QC Date

December 31, 2020

Last Update Submit

February 18, 2023

Conditions

Dialysis Access Malfunction

Keywords

Percutaneous transluminal angioplastyVolume-flow measurementAutologous arteriovenous fistulaDialysis accessInterventional Radiology

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • Re-intervention-free rate

    6 months

  • Identification of independent predictors of reintervention

    6 months

  • Procedure related complications

    1 week

Study Arms (1)

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

Interventions

Percutaneous DUS volume flow measurementsDIAGNOSTIC_TEST

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.

Volume flow group

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

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

You may not qualify if:

  • Patients with arteriovenous synthetic grafts
  • Patients with contraindication to antiplatelet therapy
  • Immature AFVs, not previously used for at least one dialysis session.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Patras Universityu Hospital

Pátrai, Achaia, Greece

Location

"Attikon" University General Hospital

Athens, Attica, 12461, Greece

Location

Nefrologiki SA Hemodialysis Centre

Athens, Attica, Greece

Location

Related Publications (1)

  • Spiliopoulos S, Filippou P, Giannikouris IE, Katsanos K, Palialexis K, Grigoriadis S, Kitrou P, Brountzos E, Karnabatidis D. US Volume Flow Assessment to Optimize Angioplasty of Dysfunctional Dialysis Access: The VOLA-II Multicenter Study. Radiology. 2024 Nov;313(2):e233076. doi: 10.1148/radiol.233076.

    PMID: 39589250DERIVED

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Interventional Radiology

Study Record Dates

First Submitted

December 31, 2020

First Posted

January 5, 2021

Study Start

June 1, 2020

Primary Completion

February 15, 2023

Study Completion

February 15, 2023

Last Updated

February 21, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

Available after study publication, upon reasonable request

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
Starting 1 month after publication and for 2 years
Access Criteria
Reasonable request (systematic review, metaanalysis)

Locations

GR(3)