Ultrasound Velocimetry in the Abdominal Aorta Before and After Endovascular Aneurysm Repair

NCT05148988 | Completed DMC

• 1 other identifier: 2021-1917
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

Rationale: An abdominal aortic aneurysm (AAA) is a common vascular disease with a high mortality in case of rupture. The underlying processes initiating aneurysmal degeneration and driving aneurysmal growth remain poorly understood. Local hemodynamics might play a key role in the pathogenesis of AAA, as it is associated with aneurysmal growth, intraluminal thrombus formation and rupture risk. Visualizing and quantifying local blood flow profiles could eventually provide more insight in the underlying mechanisms of aneurysm progression as well as identify smaller AAA with increased vulnerability or larger AAA with low risk of rupture. Consequently, this may improve risk assessment and provide patient-specific therapy guidance. Nowadays, endovascular aneurysm repair (EVAR) is the preferred treatment modality in most patients with an infrarenal AAA. However, EVAR is associated with a relatively high reintervention rate. It is hypothesized that the placement of a stent graft may alter local hemodynamics and subsequent recirculations or flow stagnations promote the onset of thrombosis or micro-emboli. These unfavourable flow conditions might be related to various complications after EVAR, such as limb occlusion, renal dysfunction, and the persistence of type II endoleaks. Visualizing local blood flow profiles after EVAR might provide insight in these (un)favourable conditions. In vivo blood flow quantification is a great challenge, particularly in the abdomen. Advanced ultrasound based techniques, incorporating ultrasound contrast agents and plane wave imaging, proved to be feasible in quantifying aortoiliac blood flow patterns in healthy volunteers. Objective: The aim of this study is to determine the feasibility of ultrafast contrast-enhanced ultrasound particle image velocimetry (echoPIV) measurements to quantify spatiotemporal blood flow velocity profiles in the abdominal aorta of AAA patients before and after endovascular repair. Secondary objectives are to determine the correlation between echoPIV and phase-contrast MRI (PC MRI) based measurements to ultimately validate the spatiotemporal velocity profiles obtained with echoPIV. Furthermore, changes in blood flow velocity profiles after placement of a stent graft will be evaluated.

Conditions

Abdominal Aortic Aneurysm

Outcome Measures

Primary Outcomes (3)

• Qualitative assessment vector velocity fields

  Vector velocity fields derived from the echoPIV data will be used to calculate and visualize the velocity profile. In order to answer the question regarding feasibility of echoPIV the quality of the vector velocity fields will be assessed using three different metrics of which the first one is a qualitative assessment by different observers. Recordings of the contrast-enhanced ultrasound with an overlay of the vector velocity profiles will be reviewed on different topics following a scoring rubrics.

  6 to 8 weeks after the procedure (endovascular repair)

• Contrast-to-background ratio

  The contrast-to-background ratio (CBR) is the second metric to assess the outcomes of the echoPIV measurements. The CBR is a quantitative measure for the contrast levels and therefore for the quality of the contrast-enhanced US image. The higher the CBR level (in dB) the higher the intensity of the contrast which is needed for sufficient PIV analysis.

  6 to 8 weeks after the procedure (endovascular repair)

• Vector correlation

  The vector correlation is the third metric to assess the outcomes of the echoPIV measurements. The vector correlation demonstrates the tracking performance of the PIV algorithm. The vector correlation provides a unitless value between 0 and 1 in which 0 indicates poor tracking of the microbubble contrast and 1 indicates perfect tracking of the microbubble contrast.

  6 to 8 weeks after the procedure (endovascular repair)

Secondary Outcomes (4)

• Correlation echoPIV and 4D flow MRI

  6 to 8 weeks after the procedure (endovascular repair)

• Influence of stent-graft placement

  6 to 8 weeks after the procedure (endovascular repair)

• Vorticity

  6 to 8 weeks after the procedure (endovascular repair)

• Vector complexity

  6 to 8 weeks after the procedure (endovascular repair)

Study Arms (1)

AAA patients

The entire cohort consists of patients with an abdominal aortic aneurysm eligible for endovascular repair using an Endurant II device.

Diagnostic Test: EchoPIV; Diagnostic Test: 4D flow MRI

Interventions

EchoPIV DIAGNOSTIC_TEST

All patients will undergo an echoPIV measurement 6 to 8 weeks before and 6 to 8 weeks after endovascular aneurysm repair. These measurements will take place at the Vascular Center of Rijnstate Hospital. A venous cannula will be inserted to enable contrast administration. Ultrasound data will be collected at the caudal renal artery, infrarenal neck, aneurysm sac and both iliac arteries.

AAA patients

4D flow MRI DIAGNOSTIC_TEST

A 4D phase-contrast magnetic resonance imaging (4D flow MRI) scan of the abdominal aorta will be obtained 6 to 8 weeks before and 6 to 8 weeks after endovascular aneurysm repair.

AAA patients

Eligibility Criteria

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

Study Population

Patients with an abdominal aortic aneurysm eligible for endovascular repair using the Endurant II device.

You may qualify if:

• Male or female \> 18 years of age
• BMI ≤ 30 kg/m2
• Infrarenal AAA
• Scheduled for elective EVAR with the Endurant II stent graft
• Informed consent form understood and signed, and agrees to all visits

You may not qualify if:

• Hypersensitivity to the active substance(s) or any of the excipients in Sonovue
• 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)
• Pregnancy

Sponsors & Collaborators

• Rijnstate Hospital: lead
• University of Twente: collaborator

Study Sites (1)

Rijnstate Hospital

Arnhem, Netherlands

Location

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Condition Hierarchy (Ancestors)

Aortic Aneurysm; Aneurysm; Vascular Diseases; Cardiovascular Diseases; Aortic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 8, 2021
• Study Start: July 6, 2022
• Primary Completion: August 22, 2023
• Study Completion: August 22, 2023
• Last Updated: November 21, 2024

Record last verified: 2024-11

Locations

NL (1)