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

NCT01907386 | Completed

• 1 other identifier: CE13.101
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Aneurysm Abdominal; Endovascular Aneurysm Repair (EVAR)

Keywords

Endoleaks; Non-invasive vascular elastography

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  Day 0: When the elastographic examinations (QSE-LSME, SSWI) and CT-scan will be completed

Study Arms (1)

QSE-LSME and SSWI ultrasound

OTHER

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

Interventions

QSE-LSME - SSWI Ultrasound OTHER

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 and SSWI ultrasound

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with at least one-year follow-up after EVAR
• Willingness to comply with study follow-up requirements
• Written informed consent

You may not qualify if:

• Patients not clinically followed by CT-scans

Sponsors & Collaborators

• Centre hospitalier de l'Université de Montréal (CHUM): lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Centre Hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, H2L 4M1, Canada

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal; Endoleak

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases; Postoperative Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications

Study Officials

• Gilles Soulez, MD, M.Sc

  Centre hospitalier de l'Université de Montréal (CHUM)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2013
• First Posted: July 25, 2013
• Study Start: January 1, 2014
• Primary Completion: December 1, 2017
• Study Completion: July 1, 2018
• Last Updated: July 20, 2018

Record last verified: 2016-09

Locations

CA (1)