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NCT Number: NCT04430478

Volume Flow-guided Angioplasty of Dysfunctional Dialysis Access

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).

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Key information

Conditions

Dialysis Access Malfunction

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

"Attikon" University General Hospital, Athens, Attica, Greece

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Volume flow guided angioplasty

Diagnostic 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.

Primary outcomes

  1. Quantification of angioplasty outcome

    Time frame: At the end of the procedure

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

  2. Duplex Ultrasound volume flow values achieved following angioplasty and clinical success

    Time frame: 1 month

    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 outcomes

  1. Re-intervention-free interval

    Time frame: 6 months

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

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

    Time frame: 6 months

    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

Sponsors and collaborators

Lead sponsor

Attikon Hospital

Other

Registry information

Official study title

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

Acronym: VOLA

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 12, 2020
Registry last updated
Dec 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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