The aim of this prospective one-year follow-up study is to investigate whether preoperative 3D US measurements of AAA characteristics with and without the use of a US contrast agent are comparable to CTA. The secondary objective is to identify…
ID
Source
Brief title
Condition
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The main study endpoint is the comparison between 3D non-CEUS, 3D CEUS and CTA
in measuring preoperative AAA characteristics, including AAA diameter, AAA
volume, lumen volume, thrombus thickness and thrombus volume.
Secondary outcome
Secondary study endpoints are:
- Feasibility of 3D CEUS of AAAs;
- Added value of contrast enhancement during 3D US;
- Category of AAA sac remodeling one-year after EVAR;
- Predictors of AAA sac remodeling one-year after EVAR.
Background summary
Abdominal aortic aneurysm (AAA) is a common vascular disease and can be treated
with endovascular repair (EVAR). Aneurysm shrinkage one-year after EVAR has
recently been shown to correlate to significantly better ten-year results after
EVAR than patients without AAA shrinkage. Preoperative prediction of AAA
shrinkage at one-year after EVAR could aid in patient selection and
optimization of EVAR, resulting in an overall higher survival rate after EVAR.
In literature, AAA thrombus, total AAA volume and lumen volume seem promising
in predicting AAA sac remodeling after EVAR, although there is not enough
evidence to draw firm conclusions yet. These 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. The PIUR 3D US system is based on electromagnetic tracking of
two-dimensional ultrasound imaging, so each ultrasound image is captured in
space and time. This results into a 3D reconstruction, and multi-planar
reconstructions of the AAA. With the use of a US contrast agent, the AAA
thrombus can also be separated from the flow lumen on the 3D scans. This way,
3D visualization of the AAA and its thrombus is enabled 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.
Study objective
The aim of this prospective one-year follow-up study is to investigate whether
preoperative 3D US measurements of AAA characteristics with and without the use
of a US contrast agent are comparable to CTA. The secondary objective is to
identify potential 3D US predictors of AAA shrinkage one-year after EVAR and
identify the added value of contrast enhancement for 3D US.
Study design
This is a prospective, explorative, cohort study.
Study burden and risks
In this prospective study, all surgical and medical procedures will be
performed according to standard care. The study protocol will collect routine
data. Efforts will be made to schedule the additional 30-40 minute 3D US
measurement subsequent to a regular hospital appointment so that patients do
not have to make an additional hospital visit for the study.The 3D US
measurement includes the use of a widely used contrast agent, SonoVue, so an IV
needs to be inserted. The scanning itself causes no additional discomfort as it
is similar to regular US scanning. With these extra measurements we gain more
knowledge of the added value of 3D US in AAA care. When confirming our
hypotheses, we expect to introduce a novel, harmless imaging method to support
clinical decision-making for AAA care. Furthermore, this study sets the first
step towards AAA care without the need for CTA with its harmful radiation,
toxic contrast agents, and higher costs.
Wagnerlaan 55
Arnhem 6815AD
NL
Wagnerlaan 55
Arnhem 6815AD
NL
Listed location countries
Age
Inclusion criteria
• Age >= 18 years;
• Unruptured infrarenal or juxtarenal abdominal aortic aneurysm (AAA);
• Scheduled for elective endovascular repair (EVAR);
• Preoperative CTA with iodine contrast scheduled or already made;
• 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.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL81910.091.22 |