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

Primary Purpose

Dialysis Access Malfunction

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Volume flow guided angioplasty
Sponsored by
Attikon Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Dialysis Access Malfunction focused on measuring Percutaneous transluminal angioplasty, Volume-flow measurment, Autologous arteriovenous fistula, Dialysis access

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • "Attikon" University General Hospital
  • Medifil SA Hemodialysis Centre
  • Nefrologiki SA Hemodialysis Centre

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Volume flow group

Arm Description

Consecutive patients undergoing sequential volume flow measurements using percutaneous DUS

Outcomes

Primary Outcome Measures

Quantification of angioplasty outcome
The quantification of angioplasty outcomes will be performed using sequential DUS volume flow analysis
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.

Secondary Outcome Measures

Re-intervention-free interval
The time interval between endovascular treatment and reintervention due to dysfunction recurrence of the treated AVF
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

Full Information

First Posted
June 10, 2020
Last Updated
December 21, 2020
Sponsor
Attikon Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04430478
Brief Title
Volume Flow-guided Angioplasty of Dysfunctional Dialysis Access
Acronym
VOLA
Official Title
VOLume Flow-guided Angioplasty of Dysfunctional Autologous Arteriovenous Fistula. The VOLA Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
June 10, 2019 (Actual)
Primary Completion Date
December 21, 2020 (Actual)
Study Completion Date
December 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Attikon Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dialysis Access Malfunction
Keywords
Percutaneous transluminal angioplasty, Volume-flow measurment, Autologous arteriovenous fistula, Dialysis access

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
QVA analysis will be performed by an investigator blinded to the volume flow analysis outcomes.
Allocation
N/A
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Volume flow group
Arm Type
Experimental
Arm Description
Consecutive patients undergoing sequential volume flow measurements using percutaneous DUS
Intervention Type
Diagnostic Test
Intervention Name(s)
Volume flow guided angioplasty
Intervention Description
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.
Primary Outcome Measure Information:
Title
Quantification of angioplasty outcome
Description
The quantification of angioplasty outcomes will be performed using sequential DUS volume flow analysis
Time Frame
At the end of the procedure
Title
Duplex Ultrasound volume flow values achieved following angioplasty and clinical success
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Re-intervention-free interval
Description
The time interval between endovascular treatment and reintervention due to dysfunction recurrence of the treated AVF
Time Frame
6 months
Title
Comparison of Duplex Ultrasound volume flow values with digital subtraction angiography QVA measurements.
Description
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
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stavros Spiliopoulos, MD, PhD, EBIR
Organizational Affiliation
ATTIKO University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
"Attikon" University General Hospital
City
Athens
State/Province
Attiki
ZIP/Postal Code
12461
Country
Greece
Facility Name
Medifil SA Hemodialysis Centre
City
Athens
State/Province
Attiki
Country
Greece
Facility Name
Nefrologiki SA Hemodialysis Centre
City
Athens
State/Province
Attiki
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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

Learn more about this trial

Volume Flow-guided Angioplasty of Dysfunctional Dialysis Access

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