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3D ultrasound of abdominal aortic aneurysm characteristics for predicting aneurysm shrinkage after endovascular repair

3D ultrasound of abdominal aortic aneurysm characteristics for predicting aneurysm shrinkage after endovascular repair - 3D US - EVAR

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON51865
Enrollment
20
Registered
2022-08-30
Start date
2023-01-02
Completion date
Unknown
Last updated
2026-01-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

abdominal aortic aneurysm dilated large abdominal bloodvessel

Interventions

None listed

Sponsors

Rijnstate Ziekenhuis
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: • BMI>40 kg/m2; • Symptomatic AAA; • Implanted pacemaker or ICD; • Unable to hold breath for 90mmHg); • Uncontrolled systemic hypertension; • Severe pulmonary disease (e.g. COPD GOLD 3 or 4, adult respiratory distress syndrome); • Clinically unstable cardiac disease (recent,

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)