Ignite Creation Date:
2024-05-06 @ 12:28 PM
Last Modification Date:
2024-10-26 @ 12:59 PM
Study NCT ID:
NCT03762525
Status:
COMPLETED
Last Update Posted:
2021-02-12
First Post:
2018-10-05
Brief Title:
Iliac Branch Device Movement During Cardiac Cycle IBD-dynamics
Sponsor:
Rijnstate Hospital
Organization:
Rijnstate Hospital
Study Overview
Official Title:
Anatomic Dynamics of the Internal Iliac Artery After Placement of Iliac Branched Devices Using ECG-gated Computer Tomography Angiography Imaging IBD-dynamics
Status:
COMPLETED
Status Verified Date:
2021-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
The choice for device is not part of this study
The choice for device is not part of this study
Detailed Description:
ObjectivesTo 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 Aand 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 Study design Sub-study A B Multicenter observational case studies Study population Sub-study A 15 prospectively included patients and sub-study B 15 patients in each group that have been treated in the period October 2006 - July 2016
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None