Information on the dynamics and shape of the device and how these change over time will improve our understanding about the fixation of the device, which may help in stent selection and in designing stent grafts that are more durable.
ID
Source
Brief title
Condition
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Of primary interest are the changes in the diameter of the stent ring due to
hemodynamic forces. We distinguish between changes during the heartbeat
(pulsatility) and changes over a period of several months (expansion).
Secondary outcome
* How does the estimated vessel compliance change over a period of several
months?
* Can we observe other kinds of motion that change over time?
Background summary
Endovascular aortic replacement (EVAR) uses stent grafts to treat aortic
aneurysms in patients at risk of aneurysm rupture. The long-term durability of
these stent grafts is hindered by complications requiring reintervention. As
most self-expanding stent grafts rely on oversizing in order to provide
sufficient sealing, the decision for the device size is critical. Once
implanted, the aorta dynamics and the device affect each other in ways that are
currently not understood. Pre- and post-operative imaging of aortic aneurysm is
routinely performed using computerised tomographic angiography (CTA). However,
these static techniques do not consider the aorta dynamics. Consequently,
measurements on the vessel diameter are relatively inaccurate, and our
understanding of the dynamic behaviour of the stent is limited. ECG-gated CTA
is a technique that takes the patient*s heart cycle into account, enabling
studies to the motion of aorta and implanted devices.
Study objective
Information on the dynamics and shape of the device and how these change over
time will improve our understanding about the fixation of the device, which may
help in stent selection and in designing stent grafts that are more durable.
Study design
Explorative observational cohort study with aortic abdominal aneurysm (AAA)
patients undergoing endovascular repair (EVAR) with Anaconda or Endurant stent
grafts.
Study burden and risks
The ECG-gated CTA protocol results in a higher dose in comparison to a routine
scan. However the additional risk on the chance of acquiring cancer as a result
of this higher dose is estimated to be negligible, because the study population
has a low life expectancy and only patients above 70 will be included.
Hallenweg 15
Enschede 7522 NH
NL
Hallenweg 15
Enschede 7522 NH
NL
Listed location countries
Age
Inclusion criteria
* Asymptomatic AAA
* Age > 70
* Indication for AAA treatment according to standard practise
* Anatomy suitable for Anaconda and/or Endurant endoprosthesis
Exclusion criteria
* No informed consent obtained
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 | NL47038.044.13 |