3D Ultrasound of Abdominal Aortic Aneurysm Characteristics

Abdominal Aortic Aneurysm Clinical Trial

— 3D US - EVAR  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05871515
• Other study ID #: 2021-1929
• Secondary ID: NL81910.091.22
• Status: Active, not recruiting
• Start date: December 27, 2022
• Est. completion date: January 2025

Study information

• Verified date: January 2024
• Source: Rijnstate Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: January 2025
• Est. primary completion date: December 13, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Abdominal Aortic Aneurysm
• Aneurysm
• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• 3D ultrasound
A 3D ultrasound is performed preoperatively to measure various aneurysm characteristics

Locations

Country	Name	City	State
Netherlands	Rijnstate Hospital	Arnhem	Non US/Canada

Sponsors (1)

Lead Sponsor	Collaborator
Rijnstate Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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