Clinical trial NCT06119100: Correlation of Ultrasonographic Lesion Type Characterization With Angioplasty Outcomes in Failing Dialysis AVFs
Official title: Characterization of STEnotic Lesion Type of Haemodialysis Arteriovenous Fistulae by Ultrasonography and Correlation With the Outcomes of Percutaneous Transluminal Angioplasty
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Dialysis Access Malfunction
Keywords: angioplasty
autologous artriovenous fistula
dialysis
ultrasound
stenosis
stenosis type characterization
Lead sponsor: Attikon Hospital
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Correlation of target lesion reintervention (TLR) due to clinical recurrence and lesion type
timeFrame: 6 months
measure: Lesion characterization
timeFrame: Less than 48 hours before the procedure
Secondary outcomes:
measure: Restenosis characterization post angioplasty
timeFrame: 6 months
measure: AVF survival
timeFrame: 6 months
measure: Binary restenosis rate
timeFrame: 6 months
measure: Periprocedural complication rate
timeFrame: Up to 48 hours post-procedure
Other outcomes:
Locations:
city: Athens
country: Greece
facility: "Attikon" University General Hospital
state: Attiki
Study officials:
References: