This study has two objectives: 1. To compare the mobility of the hypogastic artery during the cardiac cycle before and six weeks after implantation of the Gore IBE device in conjunction with its dedicated self expandable Internal Iliac component (…
ID
Source
Brief title
Condition
- Aneurysms and artery dissections
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. To compare the mobility of the hypogastic artery during the cardiac cycle
before and after implantation of the Gore IBE device (Sub-study A).
2. To quantitatively characterize the displacement during the cardiac cycle on
an implanted iliac branched endograft in conjunction with a non-dedicated n
balloon expandable IIA component (Cook IBD with Advanta V12 or Fluency) with
those in conjunction with a dedicated self expandable Internal Iliac cComponent
(Gore IBE device). (Sub-study B).
Secondary outcome
Endpoints of the study will be;
a. Displacement and angulation of the IIA component during the cardiac cycle
compared to the native outflow vessel (Sub-study A)
b. Displacement and angulation of the IIA component during the cardiac cycle
compared to the main Gore IBE device/Cook IBD (Sub-study B)
c. Tortuosity of the IIA component, defined as the difference between the
highest angles of the central luminal line of the IIA component during the
various phases.
Background summary
The incidence of isolated common iliac artery (CIA) aneurysms is low, but in
combination with an abdominal aortic aneurysm (AAA) they are found in
approximately 20-40% of cases. Basically, two different endovascular strategies
can be applied to treat a CIA aneurysm with, including 1. the coverage and 2.
the preservation of blood flow to the internal iliac artery (IIA). Coil and
coverage of the IIA is related to ischemic complications, including buttock
claudication, erectile dysfunction and the more severe spinal and colonic
ischemia. Iliac branched devices (IBD) have been developed to exclude CIA
aneurysms preserving the IIA and currently three alternatives are on the
market. Clinical results of these devices are promising but loss of patency is
not uncommon. The major difference between the two devices is the IIA
component. The Cook IBD uses a -non-dedicated IIA component, while in the GORE®
EXCLUDER® Iliac Branch Endoprosthesis (Gore IBE device) a dedicated self
expanding stent is used. Stresses and forces exerted onto the endograft by
aortic pulsatility may have an effect on the durability and functioning of the
endograft. Intermittent hinchpoints could also have an effect on stent
integrity and stenosis. By evaluating endograft movement during the cardiac
cycle (ECG-gated CTA) it is possible to assess the stress and force exerted
onto the endograft. This might help gain insight into mechanisms underlying
potential endograft failure, and aid procedural planning and the development of
future devices with long-term durability.
Study objective
This study has two objectives:
1. To compare the mobility of the hypogastic artery during the cardiac cycle
before and six weeks after implantation of the Gore IBE device in conjunction
with its dedicated self expandable Internal Iliac component (Sub-study A); 2.
To quantitatively characterize the displacement of stents with regard to the
main body and native IIA during the cardiac cycle on an implanted iliac
branched endograft in conjunction with a non-dedicated IIA component (Cook IBD
with Advanta V12 or Fluency) with those in conjunction with a dedicated self
expandable Internal Iliac component (Gore IBE device). (Sub-study B)
Both substudies will gain insight into mechanisms underlying potential
endograft failure, and aid procedural planning and the development of future
devices with long-term durability.
Study design
This study is designed as a multicenter prospective observational case series.
1. We will prospectively enroll 15 patients that are scheduled for endovascular
aneurysm repair using the Gore IBE device in conjunction with its dedicated
self expanding Internal Iliac component.
2. We will compare 15 patients that have been treated in the period October
2006- July 2016 with the Cook IBD with a non-dedicated IIA component
(Advanta-V12 or Fluency) and 15 matched patients treated with Gore IBE device.
Intervention
Routine care consists of a preoperative and several postoperative CTA scans (at
six weeks and one year following Gore IBE implantation). In A. The preoperative
and first postoperative CTA will be replaced by ECG-gated CTA imaging and in B.
Study burden and risks
More recordings will be made with a dynamic CTA in stead of a regular CTA. This
wil lead to a very small increase of the radiation exposure because of the high
speed of the dynamic CTA. Therefore, the unfavourable risks (radiation
exposure) is very small. Results of this study will give insight into which
treatment is the best for hte patients.
Wagnerlaan 55
Arnhem 6800TA
NL
Wagnerlaan 55
Arnhem 6800TA
NL
Listed location countries
Age
Inclusion criteria
• Sub-study A. scheduled endovascular aneurysm repair using the Gore IBE device.
• Sub-study B. Patients that have been treated with an iliac branched device in the past (Oct 2006-May 2018) in conjunction with either a dedicated IIA component (Gore IBE device) or non-dedicated IIA component (Cook IBD) and who are scheduled for follow-up imaging within the period July 2016-December 2018.
Exclusion criteria
No specific exclusion criteria. Patients will be treated according to the hospital*s standard practice.
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 | NL57938.091.16 |