Visualization of occult endoleaks after endovascular aortic aneurysm repair (EVAR) using Vasovist - a pilot study

Visualization of occult endoleaks after endovascular aortic aneurysm repair (EVAR) using Vasovist - a pilot study - Vasovist endoleak study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON29761

Enrollment

Registered

2006-09-19

Start date

2006-10-09

Completion date

Unknown

Last updated

2024-06-18

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

Conditions

aneurysm

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: minmally 1 years after EVAR in whom CTA demonstrated no decrease in outer diameter of the aneurysm in whom no endoleak was detected on CTA MR must be completed within 1 month after the CT examination.

Exclusion criteria

Exclusion criteria: contraindications for MRI-examination contraindication for use of contrast agent

Design outcomes

Primary

Measure	Time frame
Number of occult endoleaks only detected at late MR after positional change of the patients Endoleaks will be graded on a 5-point scale (no endoleak, possibly endoleak, probably endoleak, definitely endoleak, not diagnostic).	—

Secondary

Measure	Time frame
Number of occult endoleaks detected by - delayed CT - dynamic MRA - dynamic MRA + MRA delay 1 - MRA delay 2 - T1-w postcontrast spin echo images (delay 1) - T1-w postcontrast spin echo images (delay 2) • Number of endoleaks detected by - static MRA (first-pass) - MRA delay 1 - MRA delay 2 • Thrombus enhancement • Change in reader confidence for the detection of endoleaks	—

Countries

Netherlands

Outcome results