Volume Flow Assessment to Optimize Angioplasty of Dysfunctional Dialysis Access

Dialysis Access Malfunction Clinical Trial

— VOLAII  

Official title:

Volume Flow Assessment to Optimize Angioplasty of Dysfunctional Dialysis Access. The VOLA II Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04694287
• Other study ID #: EBD 692
• Status: Completed
• Start date: June 1, 2020
• Est. completion date: February 15, 2023

Study information

• Verified date: February 2023
• Source: Attikon Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This is a multicenter, prospective 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).

Description:

This is a prospective, multi-center, single-arm observational clinical trial investigating a new functional index of success of endovascular treatment of dysfunctional AVF assessed with intraprocedural percutaneous DUS. The study will include 100 consecutive patients undergoing fluoroscopically-guided percutaneous balloon angioplasty due to dysfunctional AVF. Exclusion criteria will be (i) patients with arteriovenous synthetic grafts. (ii) Immature AFVs not previously used for hemodialysis (at least once). 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 final balloon dilation, before sheath removal. Clinical follow-up will be set at 6 months after the index procedure. All DUS measurements will be performed using the same imaging protocol. The study's primary endpoints will be (i) the quantification of angioplasty outcome using DUS volume flow analysis before sheath insertion and at the end of the procedure before sheath removal and (ii) to assess the correlation between volume flow at the end of the procedure and clinically driven re-intervention-free rate at defined as the rate of reintervention due to dysfunction recurrence of the treated AVF. Secondary endpoints will be (i) to assess the correlation between volume flow and clinical success defined as high-quality dialysis for a period of at least one month and (ii) identification of independent predictors of re-intervention-free rate.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 15, 2023
• Est. primary completion date: February 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• Consecutive patients undergoing fluoroscopically-guided percutaneous balloon angioplasty due to dysfunctional AVF

• Signed consent form

• Agree to the study protocol

Exclusion Criteria:

• Patients with arteriovenous synthetic grafts

• Patients with contraindication to antiplatelet therapy

• Immature AFVs, not previously used for at least one dialysis session.

Related Conditions & MeSH terms

• Dialysis Access Malfunction

Intervention

Diagnostic Test:
• Percutaneous DUS volume flow measurements
Volume flow measurements of the AFV will be obtained using intraprocedural DUS just prior to sheath insertion and at the end of the final balloon dilation, before sheath removal.

Locations

Country	Name	City	State
Greece	"Attikon" University General Hospital	Athens	Attiki
Greece	Nefrologiki SA Hemodialysis Centre	Athens	Attiki
Greece	Patras Universityu Hospital	Patras	Achaia

Sponsors (3)

Lead Sponsor	Collaborator
Attikon Hospital	Nefrolgiki SA Hemodialysis Center, University Hospital of Patras

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantification of angioplasty outcome	The quantification of angioplasty outcomes will be performed using DUS volume flow analysis	At the end of the procedure
Primary	Correlation between volume flow and clinically-driven reintervention rate	The investigators will use ROC analysis to define cut off values of volume flow at the end of the procedure to predict clinically-driven reintervention rate	6 months
Secondary	Re-intervention-free rate	The clinically driven re-intervention-free rate due to dysfunction recurrence of the treated AVF following endovascular treatment	6 months
Secondary	Identification of independent predictors of reintervention	Multivariable analysis will be performed to identify independent predictors of reintervention-free rate	6 months
Secondary	Procedure related complications	Minor and major procedure related complications will be recorded	1 week