Ignite Creation Date:
2024-05-06 @ 1:49 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01907386
Status:
COMPLETED
Last Update Posted:
2018-07-20
First Post:
2013-07-22
Brief Title:
Abdominal Aortic Aneurysm Follow-up After Endovascular Repair by Non-invasive Vascular Elastography
Sponsor:
Centre hospitalier de lUniversité de Montréal CHUM
Organization:
Centre hospitalier de lUniversité de Montréal CHUM
Study Overview
Official Title:
Abdominal Aortic Aneurysm Follow-up After Endovascular Repair by Non-invasive Vascular Elastography
Status:
COMPLETED
Status Verified Date:
2016-09
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:
AAA-Elasto
Brief Summary:
Abdominal aortic aneurysm AAA is an abnormal dilatation of the aorta in the abdomen secondary to hypertension and atherosclerosis Surgical treatment of AAA is increasingly being replaced by endovascular aneurysm repair EVAR using stent-grafts SGs However the efficacy of this less invasive approach is often jeopardized by the incidence of persistent flow within the aneurysm called endoleaks leading to aneurysm rupture if not properly detected and treated Hence a life long annual CT-scan surveillance is required increasing the cost of EVAR exposing the patient to ionizing radiation and nephrotoxic contrast agent The goal of this project is to adapt and test a new ultrasound technology called ultrasound elastography to improve patient follow-up after EVAR and ultimately avoid the use of CT-scans This technique measures the deformation of the tissue secondary to blood pressure variation quasi-static elastography or to a shear wave generated by the ultrasound probe dynamic elastography The investigators will optimize 2 approaches to generate elastic maps of the AAA One approach will be a quasi-static elastography QSE-LSME technique developed by our team giving an estimation of the deformation strain of the different components of the AAA by the blood pressure The second is a dynamic elastography SSWI technique that will provide information on the elastic property of the AAA components
Detailed Description:
Experimental protocol Optimization and validation of these 2 techniques will be completed in 3 experimental phases
1 Preclinical validation Abdominal aortic aneurysm and EVAR without endoleak n6 with a type I n6 and a type II n6 endoleak will be created in 18 mongrel dogs QSE-LSME and SSWI acquisitions will be acquired before SG insertion and at 48H 1 3 months and at sacrifice at 6 months The 2 techniques will be optimized to generate strain QSE-LSME and elasticity SSWI measurements of the simulated thrombus and vessel wall CT-scan with prospective gating will be acquired on the AAA at least 6 different cardiac phases then segmented to allow 2D3D registration of CT and elastographic acquisitions Strain QSE-LSME and elasticity SSWI measurements of sac thrombus and vessel wall will be compared in the three experimental groups and correlated to sac pressure measurements CT segmentation of sac components and pathologic evaluation
2 Clinical feasibility reproducibility and correlation with CT-angiography From our EVAR database 3 groups of 15 patients will be selected based on clinical and CT-angiography evolution Group 1 will include patients without endoleak and AAA volume decrease of more than 20 following EVAR group 2 patients without endoleak and no more than 10 sac volume variation and group 3 patients with endoleak or endotension and more than 20 sac volume increase Ultrasound B-mode RF acquisitions with QSE-LSME and SSWI techniques will be acquired by two independent investigators We will compare strain values of the different AAA components in the three groups Thresholds will be tested to detect endoleak Then strain values will be correlated with diameter volume and stretch index variation between baseline and contemporary CT scans
3 Prospective study validation of strain elasticity thresholds for endoleak detection and characterization of thrombus organization The goal of this second clinical feasibility study is to collect longitudinal strain and elasticity measurements in the early post EVAR period before one-year We will include 15 patients with AAA scheduled for EVAR These patients will have a baseline CT and baseline QSE-LSME and SSWI examination Doppler ultrasound with QSE-LSME and SSWI examinations will then be performed at 3 and 12 months The variation of strain and elastic values over time frames will be analyzed and correlated volume progression and endoleak occurrence on CT scans
1 Preclinical validation Abdominal aortic aneurysm and EVAR without endoleak n6 with a type I n6 and a type II n6 endoleak will be created in 18 mongrel dogs QSE-LSME and SSWI acquisitions will be acquired before SG insertion and at 48H 1 3 months and at sacrifice at 6 months The 2 techniques will be optimized to generate strain QSE-LSME and elasticity SSWI measurements of the simulated thrombus and vessel wall CT-scan with prospective gating will be acquired on the AAA at least 6 different cardiac phases then segmented to allow 2D3D registration of CT and elastographic acquisitions Strain QSE-LSME and elasticity SSWI measurements of sac thrombus and vessel wall will be compared in the three experimental groups and correlated to sac pressure measurements CT segmentation of sac components and pathologic evaluation
2 Clinical feasibility reproducibility and correlation with CT-angiography From our EVAR database 3 groups of 15 patients will be selected based on clinical and CT-angiography evolution Group 1 will include patients without endoleak and AAA volume decrease of more than 20 following EVAR group 2 patients without endoleak and no more than 10 sac volume variation and group 3 patients with endoleak or endotension and more than 20 sac volume increase Ultrasound B-mode RF acquisitions with QSE-LSME and SSWI techniques will be acquired by two independent investigators We will compare strain values of the different AAA components in the three groups Thresholds will be tested to detect endoleak Then strain values will be correlated with diameter volume and stretch index variation between baseline and contemporary CT scans
3 Prospective study validation of strain elasticity thresholds for endoleak detection and characterization of thrombus organization The goal of this second clinical feasibility study is to collect longitudinal strain and elasticity measurements in the early post EVAR period before one-year We will include 15 patients with AAA scheduled for EVAR These patients will have a baseline CT and baseline QSE-LSME and SSWI examination Doppler ultrasound with QSE-LSME and SSWI examinations will then be performed at 3 and 12 months The variation of strain and elastic values over time frames will be analyzed and correlated volume progression and endoleak occurrence on CT scans
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None