An interventional study of QSE-LSME - SSWI Ultrasound in Aortic Aneurysm Abdominal and Endovascular Aneurysm Repair (EVAR), sponsored by Centre hospitalier de l'Université de Montréal (CHUM). Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-07-20.
Sponsored by Centre hospitalier de l'Université de Montréal (CHUM) · Not applicable, Interventional, and Diagnostic
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.
Experimental protocol: Optimization and validation of these 2 techniques will be completed in 3 experimental phases:
959 studies on the registry are indexed under Aneurysm; 174 are open to participants now.
This study's enrollment of 45 is below the median of 72 across 461 interventional studies indexed under Aneurysm.
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Exclusion Criteria:
QSE-LSME and SSWI ultrasound examinations combined with a clinically required CT-scan. We will screen 3 groups of 15 patients each, with at least one-year follow-up after EVAR, matched for sex, age and aneurysm diameter at baseline (before EVAR). Group 1. Patients without endoleak and a maximal diameter reduction at one year of at least 10% and a volume reduction of 20%. Group 2. Patients with a stable sac volume and diameter (less than 10% volume and 5% diameter variation within a year). Group 3. Patients with type I, type II or type V endoleak (endotension) with more than 10% diameter progression and 20% volume progression.
Other: QSE-LSME - SSWI Ultrasound
Doppler ultrasound (DUS) and elastographic examinations will be performed using a single probe (6-1 MHz, Super Curved, Vermon, Tours, France) with the clinical Aixplorer system (Supersonic Imagine, Aix-en-Provence, France), a new generation ultrasound scanner providing an outstanding B-mode and color-Doppler image quality, allowing exportation of RF images for QSE-LSME acquisition and integrating the shear wave elastography (SSWI) mode.
QSE-LSME
We will compare strain values of the different AAA components in the three groups Then, we will test the best combination of strain criteria defined in the preclinical optimization and validation phase among three groups to evaluate if we can define a threshold to discriminate the 3 groups.
Time frame: Day 0: When the elastographic examinations (QSE-LSME, SSWI) and CT-scan will be completed
SSWI
Elasticity values of the aortic wall and thrombus in systolic and diastolic phase will be compared in the 3 groups
Time frame: Day 0: When the elastographic examinations (QSE-LSME, SSWI) and CT-scan will be completed
This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Centre hospitalier de l'Université de Montréal (CHUM)