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

Recruiting

• Conditions: Dialysis Access Malfunction

• Registration Number: NCT06119100
• Lead Sponsor: Attikon Hospital

Brief 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.

Study Timeline

• Study Start: 2020-09-01
• Study First Submitted: 2023-10-31
• Status Verified: 2023-11
• Study First Submitted QC: 2023-11-03
• Last Update Submitted: 2023-11-03
• Study First Posted: 2023-11-07
• Last Update Posted: 2023-11-07
• Primary Completion: 2024-11-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Lesion characterization	Less than 48 hours before the procedure	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.
Correlation of target lesion reintervention (TLR) due to clinical recurrence and lesion type	6 months	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

Secondary Outcome Measures

Name	Time	Method
Restenosis characterization post angioplasty	6 months	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.
Periprocedural complication rate	Up to 48 hours post-procedure	Procedure related complications rate
Binary restenosis rate	6 months	Binary (\>50%) restenosis detected using Duplex ultrasound.
AVF survival	6 months	The overall AVF survival (secondary patency) will be recorded.

Trial Locations

Locations (1)

"Attikon" University General Hospital; 🇬🇷 Athens, Attiki, Greece