To visualize occult endoleaks in patients after endovascular abdominal aortic aneurysm repair.
ID
Source
Brief title
Condition
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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
Background summary
In patients after endovascular abdominal aortic aneurysm repair (EVAR),
life-long follow-up with imaging techniques is necessary to measure aneurysm
size and to detect endoleaks. After successful treatment, the aneurysm should
shrink. The processes which take place inside endovascularly treated aneurysms
are still unknown. If aneurysms do not shrink after endovascular treatment,
this is attributed to endoleaks. However in the case of non-shrinkage in
absence of endoleak, the etiology of the non-shrinkage is unclear. We
hypothesize still an andoleak may
be present which is not visualized by conventional imaging techniques (either
due to slow-flow or due to intermittent leakage, e.g. posture-dependency).
Study objective
To visualize occult endoleaks in patients after endovascular abdominal aortic
aneurysm repair.
Study design
Single-center pilot study
Study burden and risks
Each patient is asked to undergo one additionalMRI-scan, which includes a break
of half an hour. Normal risks and contraindications for MRI apply. The contrast
agent Vasovist is based on the magnetic properties of gadolinium. However,
contrary to normal standard gadolinium contrast agent in use for MRI, this
compound binds to human serum albumin, which prolongs the halflife of retention
in the intravascular space to 2 hours. The additional complaints expected from
this drug are comparable to the standard contrast agent.
Heidelberglaan 100
3584 CX Utrecht
Nederland
Heidelberglaan 100
3584 CX Utrecht
Nederland
Listed location countries
Age
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
Design
Recruitment
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 | NL11974.041.06 |