3D US - EVAR: 3D Ultrasound of Abdominal Aortic Aneurysm Characteristics

Sponsor

Rijnstate Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT05871515

Collaborator

(none)

Enrollment

Location

24.2

Anticipated Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

AAA characteristics are traditionally measured with computed tomography angiography (CTA), however, three-dimensional ultrasound (3D US) is emerging as a novel imaging method for AAAs. With the use of a US contrast agent, the AAA thrombus can also be distinguished from the lumen on the 3D scans. This enables 3D visualization of the AAA and its thrombus without the need for harmful radiation and nephrotoxic contrast agents, as opposed to CTA. In in vitro measurements, 3D US has already been shown to have clinically acceptable error rate with AAA diameter and volume measurement. However, it is unclear whether this is also applicable to in vivo measurements. Therefore, the aim of this prospective study is to compare preoperative 3D US AAA characteristics as measured by 3D US with contrast enhancement (3D CEUS), 3D US without contrast enhancement (3D non-CEUS) and CTA.

Condition or Disease	Intervention/Treatment	Phase
Abdominal Aortic Aneurysm	Device: 3D ultrasound

Study Design

Study Type:

Observational

Anticipated Enrollment :

20 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

3D Ultrasound of Abdominal Aortic Aneurysm Characteristics for Predicting Aneurysm Shrinkage After Endovascular Repair

Actual Study Start Date :

Dec 27, 2022

Anticipated Primary Completion Date :

Jan 1, 2024

Anticipated Study Completion Date :

Jan 1, 2025

Outcome Measures

Primary Outcome Measures

maximum AAA diameter (mm) as measured by 3D non-CEUS, 3D CEUS and CTA [Preoperatively]
For each imaging modality, the AAA and the lumen will be segmented in specialized segmentation software. Then a centerline will be computed through the lumen and perpendicular to this line, the AAA diameters are measured. From all these diameter measurements, the maximum AAA diameter will then be computed.
AAA volume (cm^3) as measured by 3D non-CEUS, 3D CEUS and CTA [Preoperatively]
For each imaging modality, the AAA will be segmented in specialized segmentation software and then the size of the volume will be computed.
lumen volume (cm^3) as measured by 3D non-CEUS, 3D CEUS and CTA [Preoperatively]
For each imaging modality, the lumen will be segmented in specialized segmentation software and then the size of the volume will be computed.
thrombus thickness (mm) as measured by 3D non-CEUS, 3D CEUS and CTA [Preoperatively]
For each imaging modality, the thrombus will be segmented in specialized segmentation software and then the thrombus thickness will be computed.
thrombus volume (cm^3) as measured by 3D non-CEUS, 3D CEUS and CTA [Preoperatively]
For each imaging modality, the thrombus will be segmented in specialized segmentation software and then the size of the volume will be computed.

Secondary Outcome Measures

Maximum AAA diameter change (mm) one-year after EVAR versus preoperative [1 year after EVAR]
Compare the maximum AAA diameter on preoperative imaging to the maximum AAA diameter on one-year imaging (within same modality). Aneurysm growth is defined as a growth of 5 mm or more, aneurysm shrinkage is defined as a shrinkage of 5 mm or more and any aneurysm with a change of less then 5 mm is considered to be stable.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Unruptured infrarenal or juxtarenal abdominal aortic aneurysm (AAA);
Scheduled for elective endovascular repair (EVAR);
Preoperative CTA with iodine contrast available;
Informed consent form understood and signed.

Exclusion Criteria:

BMI>40 kg/m2
Symptomatic AAA;
Implanted pacemaker or ICD;
Unable to hold breath for ≤7 seconds;
Pregnant;
Hypersensitivity to the active substance(s) or any of the excipients in Sonovue;
Known right-to-left cardiac shunt;
Severe pulmonary hypertension (pulmonary artery pressure > 90mmHg);
Uncontrolled systemic hypertension;
Severe pulmonary disease (e.g. COPD GOLD 3 or 4, adult respiratory distress syndrome);
Clinically unstable cardiac disease (recent, < 3 months, or ongoing myocardial infarction, unstable angina at rest, recent percutaneous coronary intervention, clinically worsening cardiac symptoms, severe cardiac arrhythmia's, endocarditis, etc.);
Prosthetic valves;
Loss of renal function (GFR < 31 mL/min), end-stage renal disease;
End-stage liver disease;
Sepsis;
Hypercoagulable status, recent (< 3 months) thrombosis;
Congestive heart failure (class III or IV);
Psychiatric or other condition that may interfere with the study;
Participating in another clinical study that interferes on the primary outcomes of this study;
3D US measurement of AAA is impossible because of bowel gasses or other causes.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rijnstate Hospital	Arnhem	Non US/Canada	Netherlands	6800 TA

Sponsors and Collaborators

Rijnstate Hospital

Investigators

Principal Investigator: Michel Reijnen, prof. dr., Rijnstate hospital, Arnhem, The Netherlands

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Rijnstate Hospital

ClinicalTrials.gov Identifier:

NCT05871515

Other Study ID Numbers:

2021-1929
NL81910.091.22

First Posted:

May 23, 2023

Last Update Posted:

May 23, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Aneurysm

Aortic Aneurysm

Aortic Aneurysm, Abdominal

Study Results

No Results Posted as of May 23, 2023