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Abdominal Aortic Aneurysm Follow-up After Endovascular Repair by Non-invasive Vascular Elastography

NCT01907386 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 45

Last updated 2018-07-20

No results posted yet for this study

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.

Conditions

  • Aortic Aneurysm Abdominal
  • Endovascular Aneurysm Repair (EVAR)

Interventions

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.

Sponsors & Collaborators

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Principal Investigators

  • Gilles Soulez, MD, M.Sc · Centre hospitalier de l'Université de Montréal (CHUM)

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2017-12-31
Completion
2018-07-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01907386 on ClinicalTrials.gov