Information on the dynamics and shape of the stent graft and stented target vessels and how these change over time will improve our understanding about the fixation and/or sealing of the device, which may help in stent graft selection and in…
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 and the changes in the dynamic interaction between the main
body, the branches, and the renal and/or mesenteric arteries. We distinguish
between changes during the heartbeat (pulsatility) and changes over a period of
several months (expansion).
Secondary outcome
* How does implantation of the Fenestrated Anaconda* stent graft with stenting
of the target vessels influence the movement of the aorta, renal arteries and
mesenteric arteries? * 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
Fenestrated endovascular aortic repair (F-EVAR) uses stent grafts with
customized fenestrations to treat complex aortic aneurysms in patients at risk
of aneurysm rupture. The long-term durability of these stent grafts is hindered
by complications requiring reintervention. Especially the perirenal fixation
and sealing area is of vital importance. The customized fenestrations in the
stent graft are cannulated with stents into the renal and/or mesenteric
arteries, challenging the perirenal fixation. 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, our
understanding of the dynamic behaviour of the stent graft and stented target
vessels 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 stent graft and stented target
vessels and how these change over time will improve our understanding about the
fixation and/or sealing of the device, which may help in stent graft selection
and in designing stent grafts that are more durable
Study design
Explorative observational cohort study with patients with an aortic abdominal
aneurysm (AAA) undergoing endovascular repair with the fenestrated Anaconda*
stent graft (F-EVAR).
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 65 will be included.
DRIENERLOLAAN 5
Enschede 7522 NB
NL
DRIENERLOLAAN 5
Enschede 7522 NB
NL
Listed location countries
Age
Inclusion criteria
Asymptomatic AAA * Age > 65 * Indication for AAA treatment according to
standard practise * Anatomic suitability for the Fenestrated Anaconda* stent
graft * At least one stentable main renal artery and one other stentable renal
or mesenteric artery
Exclusion criteria
No informed consent obtained * eGFR < 30 ml/min * Allergy for intra venous
contrast fluid
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL59794.044.16 |
| Other | NTR- [te ontvangen identificatienummer] |
| OMON | NL-OMON24358 |