Correlation of Ultrasonographic Lesion Type Characterization With Angioplasty Outcomes in Failing Dialysis AVFs (STELA)

Characterization of STEnotic Lesion Type of Haemodialysis Arteriovenous Fistulae by Ultrasonography and Correlation With the Outcomes of Percutaneous Transluminal Angioplasty

The continuous increase in the incidence of end stage renal disease and hemodialysis patients, has raised the interest of the vascular access scientific community and many researchers are currently investigating the potential mechanisms of arteriovenous fistulas (AVF) dysfunction. Roy-Chaudhury et al. were the first to suggest neointimal hyperplasia (NIH) as the main reason of AVF dysfunction and vessel negative remodeling as another important factor. First, Yamamoto et al. described 3 stenotic lesions categories of arteriovenous grafts (AVG) observed by ultrasonography: 1. vascular constriction type, 2. neointimal hyperplasia type, 3. mixed type (constriction and neointimal hyperplastic type).

The main goals of this prospective observetional study are:

• The characterization of AVF stenotic lesions by ultrasonography
• The correlation of the stenotic lesion type with the outcomes of percutaneous transluminal angioplasty and the rate of reintervention.

Study Overview

• Status: Recruiting
• Conditions: Dialysis Access Malfunction
• Intervention / Treatment: Diagnostic test: Ultrasound characterization of stenotic lesion type

Detailed Description

This is a prospective, observetional study designed to investigate the correlation of stenotic lesion type characterization (1. vascular constriction type, 2. neointimal hyperplasia type, 3. mixed type eg. constriction and neointimal hyperplastic type) using Duplex ultrasound, with the outcomes of high pressure plain balloon angioplasty. In total 200 patients with failing dialysis arteriovenoyus fistula (AVF) scheduled to undergo angioplasty of stenotic lesion(s) will be included. The study's primary endpoint will be the correlation between stenotic lesion type and target lesion re-intervention due to clinical recurrence at 6 months follow up.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

Study Locations

• Greece
  • Attiki
    • Athens, Attiki, Greece, 12461
      • Recruiting
      • "ATTIKON" University General Hospital
      • Contact: Stavros Spiliopoulos, MD, PhD,; Phone Number: 6937403468; Email: stavspiliop@med.uoa.gr
      • Contact: Anastasia Karachaliou, MD; Phone Number: +306936164692; Email: anastasia.karachaliou4@gmail.com
      • Sub-Investigator: Anastasia Karachaliou, MD
      • Principal Investigator: Stavros Spiliopoulos, MD, PhD
      • Sub-Investigator: Kostantinos Palialexis, MD, PhD
      • Sub-Investigator: Panagiotis Filippou, MD
      • Sub-Investigator: Stavros Grigoriadis, MD, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patiens between 18and 90 years of age, reffered due to failing AVF and scheduled to undergo fluoroscopically-guided, high-pressure balloon angioplasty of a significant stenosis within the dialysis access circuite.

Description

Inclusion Criteria:

• Patiens with failing AVF scheduled to undergo fluoroscopically-guided high-pressure balloon angioplasty
• Signed study concent form

Exclusion Criteria:

• Patients undergoing dialysis via arteriovenous graft (AVG)
• Contraindications to angioplasty
• Immature AVF

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Correlation of target lesion reintervention (TLR) due to clinical recurrence and lesion type	The correlation of the speciific lesion type classified based on the pre-procedural ultrasonographic assessment and the target lesion reintervention rate due to clinical recurrence, will be investigated	6 months
Lesion characterization	Lesion type will be classified as restrictive, hyperplastic or mixed based on the pre-procedural Duplex ultrasound assessment and the rates of each type will be recorded.	Less than 48 hours before the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Restenosis characterization post angioplasty	restenosis type will be classified as restrictive, hyperplastic or mixed based on the 6 months Duplex ultrasound assessment and the rates of each type will be recorded.	6 months
AVF survival	The overall AVF survival (secondary patency) will be recorded.	6 months
Binary restenosis rate	Binary (>50%) restenosis detected using Duplex ultrasound.	6 months
Periprocedural complication rate	Procedure related complications rate	Up to 48 hours post-procedure

Collaborators and Investigators

• Sponsor: Attikon Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2020
• Primary Completion (Estimated): November 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: October 31, 2023
• First Submitted That Met QC Criteria: November 3, 2023
• First Posted (Actual): November 7, 2023

Study Record Updates

• Last Update Posted (Actual): November 7, 2023
• Last Update Submitted That Met QC Criteria: November 3, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: ultrasound; dialysis; stenosis; angioplasty; autologous artriovenous fistula; stenosis type characterization
• Other Study ID Numbers: 77758

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No