Aortic Aneurysm AbdominalAAA-ElastoNCT01907386
Abdominal Aortic Aneurysm Follow-up After Endovascular Repair by Non-invasive Vascular Elastography
A study testing QSE-LSME - SSWI Ultrasound in people with Aortic Aneurysm Abdominal and Endovascular Aneurysm Repair (EVAR), run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Aneurysm Abdominal, Endovascular Aneurysm Repair (EVAR)
- What is being tested?
- QSE-LSME - SSWI Ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2014to Jul 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with at least one-year follow-up after EVAR
- Willingness to comply with study follow-up requirements
- Written informed consent
Who cannot join
- Patients not clinically followed by CT-scans
Trial locations and contacts
1 site in 1 country.
Canada1 site
Centre Hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, H2L 4M1
About this study
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.
Read the detailed description
Experimental protocol: Optimization and validation of these 2 techniques will be completed in 3 experimental phases:
- Preclinical validation: Abdominal aortic aneurysm and EVAR without endoleak (n=6), with a type I (n=6) and a type II (n=6) 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 2D/3D 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.
- 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.
- 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.
- Being tested
- QSE-LSME - SSWI Ultrasound
- Keywords
- Endoleaks, Non-invasive vascular elastography
- Medical subject headings
- Aortic Aneurysm, Abdominal, Endoleak
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QSE-LSME - SSWI UltrasoundOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: QSE-LSME - SSWI Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: Day 0: When the elastographic examinations (QSE-LSME, SSWI) and CT-scan will be completed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startJan 2014
- Primary completionDec 2017
- Study completionJul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Aneurysm AbdominalStudies of the same condition, open and under way.
- More trials run by Centre hospitalier de l'Université de Montréal (CHUM)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Gilles Soulez, MD, M.Sc, Principal investigator, Centre hospitalier de l'Université de Montréal (CHUM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01907386
- Sponsor's protocol ID
- CE13.101
- Acronym
- AAA-Elasto
- Status last verified
- Sep 2016
- First submitted
- 22 Jul 2013
- Last updated
- 20 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Abdominal Aortic Aneurysm Follow-up After Endovascular Repair by Non-invasive Vascular Elastography
- ClinicalTrials.gov ID
- NCT01907386
- Acronym / sponsor ID
- AAA-Elasto / CE13.101
- Keywords
- Endoleaks, Non-invasive vascular elastography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Centre hospitalier de l'Université de Montréal (CHUM)University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Jan 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Jul 2018 (actual)
- First posted
- 25 Jul 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Preclinical validation: Abdominal aortic aneurysm and EVAR without endoleak (n=6), with a type I (n=6) and a type II (n=6) 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 2D/3D 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.
- 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.
- 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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| QSE-LSME and SSWI ultrasound | Other | Other: QSE-LSME - SSWI UltrasoundQSE-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with at least one-year follow-up after EVAR
- Willingness to comply with study follow-up requirements
- Written informed consent
Key exclusion criteria (1 listed)
- Patients not clinically followed by CT-scans
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| QSE-LSME - SSWI UltrasoundDoppler 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. | Other | QSE-LSME and SSWI ultrasound |
Primary outcome
QSE-LSME
Time frame: Day 0: When the elastographic examinations (QSE-LSME, SSWI) and CT-scan will be completed
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.
SSWI
Time frame: Day 0: When the elastographic examinations (QSE-LSME, SSWI) and CT-scan will be completed
Elasticity values of the aortic wall and thrombus in systolic and diastolic phase will be compared in the 3 groups
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gilles Soulez, MD, M.Sc principal investigator
Centre hospitalier de l'Université de Montréal (CHUM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing QSE-LSME - SSWI Ultrasound in people with Aortic Aneurysm Abdominal and Endovascular Aneurysm Repair (EVAR), run by Centre hospitalier de l'Université de Montréal (CHUM) at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QSE-LSME (time frame: Day 0: When the elastographic examinations (QSE-LSME, SSWI) and CT-scan will be completed). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2018.