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Volume Flow-guided Angioplasty of Dysfunctional Dialysis Access

NCT ID: NCT04430478

Last Updated: 2020-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-10

Study Completion Date

2020-12-21

Brief Summary

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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

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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.

Conditions

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Dialysis Access Malfunction

Keywords

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Percutaneous transluminal angioplasty Volume-flow measurment Autologous arteriovenous fistula Dialysis access

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

QVA analysis will be performed by an investigator blinded to the volume flow analysis outcomes.

Study Groups

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Volume flow group

Consecutive patients undergoing sequential volume flow measurements using percutaneous DUS

Group Type EXPERIMENTAL

Volume flow guided angioplasty

Intervention Type 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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Attikon Hospital

OTHER

Sponsor Role lead

Responsible Party

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Stavros Spiliopoulos

Assistant Professor in Interventional Radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stavros Spiliopoulos, MD, PhD, EBIR

Role: PRINCIPAL_INVESTIGATOR

ATTIKO University Hospital

Locations

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"Attikon" University General Hospital

Athens, Attica, Greece

Site Status

Medifil SA Hemodialysis Centre

Athens, Attica, Greece

Site Status

Nefrologiki SA Hemodialysis Centre

Athens, Attica, Greece

Site Status

Countries

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Greece

Other Identifiers

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323

Identifier Type: -

Identifier Source: org_study_id