NCT06119100

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 200 (estimated)
• Sponsor: Attikon Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Dialysis Access Malfunction

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Ultrasound characterization of stenotic lesion type	Target lesion type will be classified as restrictive, hyperplastic or mixed using high frequency Duplex ultrasound, before the angioplasty procedure and at 6 months follow up.

Timeline

• Start date: 2020-09-01
• Primary completion: 2024-11-01
• Completion: 2024-12-01
• First posted: 2023-11-07
• Last updated: 2023-11-07

Locations

1 site across 1 country: Greece