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

NCT06119100 | Unknown

• 1 other identifier: 77758
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Dialysis Access Malfunction

Keywords

angioplasty; autologous artriovenous fistula; dialysis; ultrasound; stenosis; stenosis type characterization

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Restenosis characterization post angioplasty

  6 months

• AVF survival

  6 months

• Binary restenosis rate

  6 months

• Periprocedural complication rate

  Up to 48 hours post-procedure

Interventions

Ultrasound characterization of stenotic lesion type DIAGNOSTIC_TEST

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.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Attikon Hospital: lead

Study Sites (1)

"Attikon" University General Hospital

Athens, Attica, 12461, Greece

RECRUITING

MeSH Terms

Conditions

Constriction, Pathologic

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Diagnostic and Interventional Radiology

Study Record Dates

• First Submitted: October 31, 2023
• First Posted: November 7, 2023
• Study Start: September 1, 2020
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

GR (1)