NCT04430478

Brief Summary

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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2019

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 10, 2019

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 10, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 12, 2020

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 21, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 21, 2020

Completed
Last Updated

December 22, 2020

Status Verified

December 1, 2020

Enrollment Period

1.5 years

First QC Date

June 10, 2020

Last Update Submit

December 21, 2020

Conditions

Dialysis Access Malfunction

Keywords

Percutaneous transluminal angioplastyVolume-flow measurmentAutologous arteriovenous fistulaDialysis access

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Re-intervention-free interval

    6 months

  • Comparison of Duplex Ultrasound volume flow values with digital subtraction angiography QVA measurements.

    6 months

Study Arms (1)

Volume flow group

EXPERIMENTAL

Consecutive patients undergoing sequential volume flow measurements using percutaneous DUS

Diagnostic Test: Volume flow guided angioplasty

Interventions

Volume flow guided angioplastyDIAGNOSTIC_TEST

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.

Volume flow group

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

"Attikon" University General Hospital

Athens, Attica, 12461, Greece

Location

Medifil SA Hemodialysis Centre

Athens, Attica, Greece

Location

Nefrologiki SA Hemodialysis Centre

Athens, Attica, Greece

Location

Study Officials

  • Stavros Spiliopoulos, MD, PhD, EBIR

    ATTIKO University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
QVA analysis will be performed by an investigator blinded to the volume flow analysis outcomes.
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: The study will include consecutive patients undergoing fluoroscopically-guided percutaneous balloon angioplasty due to dysfunctional AVF. 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, while fistulograms with QVA analysis will be performed at 6 and 12 months.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor in Interventional Radiology

Study Record Dates

First Submitted

June 10, 2020

First Posted

June 12, 2020

Study Start

June 10, 2019

Primary Completion

December 21, 2020

Study Completion

December 21, 2020

Last Updated

December 22, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will share

The investigators plan to make individual participant data (IPD) available to other researchers upon request.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR
Time Frame
After the publication of the study, indefinitely
Access Criteria
Other researchers upon request

Locations

GR(3)