Ignite Creation Date:
2024-05-06 @ 1:52 PM
Last Modification Date:
2024-10-26 @ 1:21 PM
Study NCT ID:
NCT04141852
Status:
COMPLETED
Last Update Posted:
2021-11-26
First Post:
2019-10-11
Brief Title:
VasQ and Hemodynamic Conditions in AVFs
Sponsor:
Mario Negri Institute for Pharmacological Research
Organization:
Mario Negri Institute for Pharmacological Research
Study Overview
Official Title:
Arterovenous Fistula Surgery With the VasQ Support Device The Effects on Hemodynamic Conditions - Pilot Study
Status:
COMPLETED
Status Verified Date:
2021-11
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:
RESHAPE
Brief Summary:
End-stage renal disease ESRD is a growing global health problem strictly connected with progressive ageing population and longer survival of patients living on renal replacement therapy The majority of ESRD patients is on hemodialysis HD treatment A successful HD procedure requires a functional vascular access VA to provide safe and long-lasting way to connect patient circulation to the artificial kidney To date VA dysfunction is the major cause of morbidity and hospitalisation in HD patients and the major limitation of HD treatment The current recommendation for VA is the native artero-venous fistula AVF surgically created in the forearm but is still affected by high non-maturation and early failure rates The most common cause of AVF early-failure is vascular stenosis due to neointimal hyperplasia NH Despite the exact mechanisms underlying stenosis development remain tentative there is general consensus that hemodynamic conditions play a key role in the formation of NH Previous computational fluid dynamics CFD investigations inside patient-specific AVF models conducted by our group revealed transitional laminar-to-turbulent flow in the juxta-anastomotic vein
Various vascular access devices have been designed to incorporate features to regularize the hemodynamics and favour spiral flow development in the venous segment of the AVF The VasQ external support device Laminate Medical Technologies Israel is a novel Nitinol implant externally surrounding and supporting the vein and hugging the artery near the junction site without being in contact with the blood flow
VasQ attempts at constraining and shaping geometrical parameters of the AVF as well as reinforcing the vulnerable perianastomotic vein against high pressure wall tension and flow levels A prospective single-centre study demonstrated the safety of the VasQ external support device but the effect of its use on hemodynamic conditions and the advantages in terms of flow regularization in patient-specific AVFs still need to be investigated
A detailed analysis of the local blood flow field in patient-specific AVFs can be obtained coupling non contrast-enhanced MRI NCE-MRI and high-resolution CFD simulations using a NCE-MRI protocol recently optimized by our group Our MRI sequence has the advantage of providing high-quality images in a short acquisition time of 5-10 minutes compared to other MRI protocols that require more than 45 minutes for a single acquisition Combined with high-resolution CFD our MRI-to-CFD pipeline allowed us to characterize morphological and hemodynamic changes in the AVF of one patient at two timepoints immediately after AVF surgery and at AVF maturation Therefore it seems to be a promising approach to perform morphological and hemodynamic analysis also in AVF created using the VasQ device and can be used to elucidate the effects of VasQ device on hemodynamic conditions as compared to hemodynamic conditions present in AVFs created using conventional surgery without the use of any device
Various vascular access devices have been designed to incorporate features to regularize the hemodynamics and favour spiral flow development in the venous segment of the AVF The VasQ external support device Laminate Medical Technologies Israel is a novel Nitinol implant externally surrounding and supporting the vein and hugging the artery near the junction site without being in contact with the blood flow
VasQ attempts at constraining and shaping geometrical parameters of the AVF as well as reinforcing the vulnerable perianastomotic vein against high pressure wall tension and flow levels A prospective single-centre study demonstrated the safety of the VasQ external support device but the effect of its use on hemodynamic conditions and the advantages in terms of flow regularization in patient-specific AVFs still need to be investigated
A detailed analysis of the local blood flow field in patient-specific AVFs can be obtained coupling non contrast-enhanced MRI NCE-MRI and high-resolution CFD simulations using a NCE-MRI protocol recently optimized by our group Our MRI sequence has the advantage of providing high-quality images in a short acquisition time of 5-10 minutes compared to other MRI protocols that require more than 45 minutes for a single acquisition Combined with high-resolution CFD our MRI-to-CFD pipeline allowed us to characterize morphological and hemodynamic changes in the AVF of one patient at two timepoints immediately after AVF surgery and at AVF maturation Therefore it seems to be a promising approach to perform morphological and hemodynamic analysis also in AVF created using the VasQ device and can be used to elucidate the effects of VasQ device on hemodynamic conditions as compared to hemodynamic conditions present in AVFs created using conventional surgery without the use of any device
Detailed Description:
None
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