Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06119100
Status:
RECRUITING
Last Update Posted:
2023-11-07
First Post:
2023-10-31
Brief Title:
Correlation of Ultrasonographic Lesion Type Characterization With Angioplasty Outcomes in Failing Dialysis AVFs
Sponsor:
Attikon Hospital
Organization:
Attikon Hospital
Study Overview
Official Title:
Characterization of STEnotic Lesion Type of Haemodialysis Arteriovenous Fistulae by Ultrasonography and Correlation With the Outcomes of Percutaneous Transluminal Angioplasty
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
STELA
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
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 lesions will be included The studys 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None