3D Ultrasound of Abdominal Aortic Aneurysm Characteristics (3D US - EVAR)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Abdominal Aortic Aneurysm
• Intervention / Treatment: Device: 3D ultrasound

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

Study Locations

• Netherlands
  • Non US/Canada
    • Arnhem, Non US/Canada, Netherlands, 6800 TA
      • Rijnstate Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

20 subjects with an AAA who are up for EVAR treatment will be included. Participants will be recruited from the Rijnstate hospital.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
maximum AAA diameter (mm) as measured by 3D non-CEUS, 3D CEUS and CTA	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.	Preoperatively
AAA volume (cm^3) as measured by 3D non-CEUS, 3D CEUS and CTA	For each imaging modality, the AAA will be segmented in specialized segmentation software and then the size of the volume will be computed.	Preoperatively
lumen volume (cm^3) as measured by 3D non-CEUS, 3D CEUS and CTA	For each imaging modality, the lumen will be segmented in specialized segmentation software and then the size of the volume will be computed.	Preoperatively
thrombus thickness (mm) as measured by 3D non-CEUS, 3D CEUS and CTA	For each imaging modality, the thrombus will be segmented in specialized segmentation software and then the thrombus thickness will be computed.	Preoperatively
thrombus volume (cm^3) as measured by 3D non-CEUS, 3D CEUS and CTA	For each imaging modality, the thrombus will be segmented in specialized segmentation software and then the size of the volume will be computed.	Preoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum AAA diameter change (mm) one-year after EVAR versus preoperative	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.	1 year after EVAR

Collaborators and Investigators

• Sponsor: Rijnstate Hospital
• Investigators: Principal Investigator: Michel Reijnen, prof. dr., Rijnstate Hospital, Arnhem, The Netherlands

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2022
• Primary Completion (Actual): December 13, 2023
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: April 3, 2023
• First Submitted That Met QC Criteria: May 12, 2023
• First Posted (Actual): May 23, 2023

Study Record Updates

• Last Update Posted (Estimated): February 1, 2024
• Last Update Submitted That Met QC Criteria: January 31, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: 2021-1929; NL81910.091.22 (Other Identifier: CCMO)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No