Ignite Creation Date:
2024-05-06 @ 4:56 PM
Last Modification Date:
2024-10-26 @ 2:19 PM
Study NCT ID:
NCT05148988
Status:
COMPLETED
Last Update Posted:
2023-09-26
First Post:
2021-11-24
Brief Title:
Ultrasound Velocimetry in the Abdominal Aorta Before and After Endovascular Aneurysm Repair
Sponsor:
Rijnstate Hospital
Organization:
Rijnstate Hospital
Study Overview
Official Title:
Feasibility of Ultrasound Particle Image Velocimetry to Quantify Flow in the Abdominal Aorta Before and After Endovascular Aneurysm Repair
Status:
COMPLETED
Status Verified Date:
2023-09
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:
EchoPIV in AAA
Brief Summary:
Rationale An abdominal aortic aneurysm AAA is a common vascular disease with a high mortality in case of rupture The underlying processes initiating aneurysmal degeneration and driving aneurysmal growth remain poorly understood Local hemodynamics might play a key role in the pathogenesis of AAA as it is associated with aneurysmal growth intraluminal thrombus formation and rupture risk Visualizing and quantifying local blood flow profiles could eventually provide more insight in the underlying mechanisms of aneurysm progression as well as identify smaller AAA with increased vulnerability or larger AAA with low risk of rupture Consequently this may improve risk assessment and provide patient-specific therapy guidance Nowadays endovascular aneurysm repair EVAR is the preferred treatment modality in most patients with an infrarenal AAA However EVAR is associated with a relatively high reintervention rate It is hypothesized that the placement of a stent graft may alter local hemodynamics and subsequent recirculations or flow stagnations promote the onset of thrombosis or micro-emboli These unfavourable flow conditions might be related to various complications after EVAR such as limb occlusion renal dysfunction and the persistence of type II endoleaks Visualizing local blood flow profiles after EVAR might provide insight in these unfavourable conditions In vivo blood flow quantification is a great challenge particularly in the abdomen Advanced ultrasound based techniques incorporating ultrasound contrast agents and plane wave imaging proved to be feasible in quantifying aortoiliac blood flow patterns in healthy volunteers
Objective The aim of this study is to determine the feasibility of ultrafast contrast-enhanced ultrasound particle image velocimetry echoPIV measurements to quantify spatiotemporal blood flow velocity profiles in the abdominal aorta of AAA patients before and after endovascular repair
Secondary objectives are to determine the correlation between echoPIV and phase-contrast MRI PC MRI based measurements to ultimately validate the spatiotemporal velocity profiles obtained with echoPIV Furthermore changes in blood flow velocity profiles after placement of a stent graft will be evaluated
Objective The aim of this study is to determine the feasibility of ultrafast contrast-enhanced ultrasound particle image velocimetry echoPIV measurements to quantify spatiotemporal blood flow velocity profiles in the abdominal aorta of AAA patients before and after endovascular repair
Secondary objectives are to determine the correlation between echoPIV and phase-contrast MRI PC MRI based measurements to ultimately validate the spatiotemporal velocity profiles obtained with echoPIV Furthermore changes in blood flow velocity profiles after placement of a stent graft will be evaluated
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