Clinical trial NCT04430478: Volume Flow-guided Angioplasty of Dysfunctional Dialysis Access
Official title: VOLume Flow-guided Angioplasty of Dysfunctional Autologous Arteriovenous Fistula. The VOLA Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dialysis Access Malfunction
Keywords: Percutaneous transluminal angioplasty
Volume-flow measurment
Autologous arteriovenous fistula
Dialysis access
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
First posted: 2020-06-12
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: DIAGNOSTIC

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.

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.

Primary outcomes:
measure: Quantification of angioplasty outcome
timeFrame: At the end of the procedure
measure: Duplex Ultrasound volume flow values achieved following angioplasty and clinical success
timeFrame: 1 month
Secondary outcomes:
measure: Re-intervention-free interval
timeFrame: 6 months
measure: Comparison of Duplex Ultrasound volume flow values with digital subtraction angiography QVA measurements.
timeFrame: 6 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: "Attikon" University General Hospital
state: Attiki
city: Athens
country: Greece
facility: Medifil SA Hemodialysis Centre
state: Attiki
city: Athens
country: Greece
facility: Nefrologiki SA Hemodialysis Centre
state: Attiki
Study officials:
affiliation: ATTIKO University Hospital
name: Stavros Spiliopoulos, MD, PhD, EBIR
role: PRINCIPAL_INVESTIGATOR
References: