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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:
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| AVF survival |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| "Attikon" University General Hospital | Recruiting | Athens | Attica | 12461 | Greece |
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| ID | Term |
|---|---|
| D003251 | Constriction, Pathologic |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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The overall AVF survival (secondary patency) will be recorded.
| 6 months |
| Binary restenosis rate | Binary (>50%) restenosis detected using Duplex ultrasound. | 6 months |
| Periprocedural complication rate | Procedure related complications rate | Up to 48 hours post-procedure |