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

Brief Title

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

Official Title

Feasibility of Ultrasound Particle Image Velocimetry to Quantify Flow in the Abdominal Aorta Before and After Endovascular Aneurysm Repair

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.
    

Study Type

Observational

Primary Outcome

Qualitative assessment vector velocity fields

Secondary Outcome

 Correlation echoPIV and 4D flow MRI

Condition

Abdominal Aortic Aneurysm

Intervention

EchoPIV

Study Arms / Comparison Groups

 AAA patients

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Status

Diagnostic Test

Estimated Enrollment

10

Start Date

November 24, 2021

Completion Date

November 1, 2022

Primary Completion Date

November 1, 2022

Eligibility Criteria

        Inclusion Criteria:

          -  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

        Exclusion Criteria:

          -  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

          -  MRI exclusion criteria (pacemakers, cerebral vascular clips, claustrophobia)
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

, +31 88 005 7282, [email protected]

Location Countries

Netherlands

Location Countries

Netherlands

NCT ID

NCT05148988

Organization ID

2021-1917

Responsible Party

Sponsor

Study Sponsor

Rijnstate Hospital

Collaborators

 University of Twente

Study Sponsor

, , 

Verification Date

November 2021