ow-field MRI visualisation of gravity-dependent endograft migration in patients with suspected endoleaks after EVAR (endovascular aneurysm repair)

Completed

Conditions: Aorta dilation
10002363

Registration Number: NL-OMON48077

Lead Sponsor: niversiteit Twente

Brief Summary: Trial is onging in other countries

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 10

Inclusion Criteria

- Patient had previous EVAR intervention
- Implanted endograft: type Endurant or type Anaconda
- Patient had/will have CTA follow-up because of a suspected endoleak, or
growth of the aneurysm
- Signed informed consent
- Good knowledge of Dutch language

Exclusion Criteria

- Hip waist > 47 cm (because of MR coil restrictions)
- Not eligible for MRI, in response to the MRI safety checklist
- Inability to stand for 15 minutes, without assistance
- Outdated (>2 months) good contrast CTA scan
- Previous re-intervention to repair an endoleak after EVAR

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The aim of this explorative study is to evaluate existing geometrical<br /><br>parameters that are developed for supine imaging examinations (angles,<br /><br>distances, surfaces, changes with respect to the spine) in upright scanning and<br /><br>to assess whether these parameters deteriorate from supine to upright MRI<br /><br>scanning.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To evaluate if there is a correlation between the geometrical parameters<br /><br>obtained from the MR images with the measurements on CTA examinations that are<br /><br>made in clinical practice.<br /><br>- To explore if additional parameters can be defined, based on the upright MRI<br /><br>scan, that may be of interest to the surgeon and outcome of surgical treatment,<br /><br>which can be further tested for their clinical merit in a future trial.</p><br>