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

Dialysis Access Malfunction Clinical Trial

— STELA  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06119100
• Other study ID #: 77758
• Status: Recruiting
• Start date: September 1, 2020
• Est. completion date: December 1, 2024

Study information

• Verified date: November 2023
• Source: Attikon Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 1, 2024
• Est. primary completion date: November 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Dialysis Access Malfunction

Intervention

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.

Locations

Country	Name	City	State
Greece	"Attikon" University General Hospital	Athens	Attiki

Sponsors (1)

Lead Sponsor	Collaborator
Attikon Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	AVF survival	The overall AVF survival (secondary patency) will be recorded.	6 months
Secondary	Binary restenosis rate	Binary (>50%) restenosis detected using Duplex ultrasound.	6 months
Secondary	Periprocedural complication rate	Procedure related complications rate	Up to 48 hours post-procedure