Visualization of occult endoleaks after endovascular aortic aneurysm repair (EVAR) using Vasovist - a pilot study
Completed
- Conditions
- aneurysm10002363
- Registration Number
- NL-OMON29761
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
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
contraindications for MRI-examination
contraindication for use of contrast agent
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Number of occult endoleaks only detected at late MR after positional change of<br /><br>the patients<br /><br>Endoleaks will be graded on a 5-point scale (no endoleak, possibly endoleak,<br /><br>probably endoleak, definitely endoleak, not diagnostic).</p><br>
- Secondary Outcome Measures
Name Time Method <p>Number of occult endoleaks detected by<br /><br>- delayed CT<br /><br>- dynamic MRA<br /><br>- dynamic MRA + MRA delay 1<br /><br>- MRA delay 2<br /><br>- T1-w postcontrast spin echo images (delay 1)<br /><br>- T1-w postcontrast spin echo images (delay 2)<br /><br>• Number of endoleaks detected by<br /><br>- static MRA (first-pass)<br /><br>- MRA delay 1<br /><br>- MRA delay 2<br /><br>• Thrombus enhancement<br /><br>• Change in reader confidence for the detection of endoleaks</p><br>