Dynamic Computed Tomography Angiography (CTA) Follow-up for EndoVascular Aortic Replacement (EVAR)
Recruitment status was Recruiting
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The Value of Dynamic CTA During the Follow-up of EndoVascular Aortic Replacement (EVAR): a Pilot Study|
- to quantitatively characterize the stresses and forces on an implanted endograft during the cardiac cycle in terms of longitudinal movement [ Time Frame: n.a. ] [ Designated as safety issue: No ]
- evaluate the integrity of the endograft by visualization using CT in the longitudinal and transversal plane at several moments during the cardiac cycle versus the standard transverse plane method [ Time Frame: n.a. ] [ Designated as safety issue: No ]
|Study Start Date:||January 2007|
|Estimated Study Completion Date:||December 2009|
|Estimated Primary Completion Date:||September 2008 (Final data collection date for primary outcome measure)|
Preoperative patients planned for a CT prior to an endograft implantation procedure
Patients who underwent a complicated endograft implant and/or with increased risk of complications
Endovascular Aortic replacement (EVAR) for the treatment of aortic aneurysms in patients at risk of aneurysm rupture is an established endovascular technique (ref: Blankensteijn, NEJM, 2005). However, the development of the endograft design is ongoing in order to prevent late endograft failure (e.g. graft breakage, graft displacement). The stresses and forces applied to the endograft by the high physiological forces and stresses in the aorta have an effect on the durability and functioning of the endograft. The stresses and forces that occur during movement may be reflected by movement of the endograft itself during the cardiac cycle. Standard patient follow-up involves transverse CT imaging to detect endograft leakage. However, transverse imaging does not provide information on endograft displacement but does provide information on shrinkage of the aneurysm after endograft placement. Therefore, additional information on the longitudinal displacement of the endograft during the cardiac cycle may assist in determining the optimal characteristics of a durable endograft and therefore benefit the patient in the long-term. Evaluation of the stresses and forces by calculating longitudinal displacement of the endograft appears possible by applying a cardiac CT technique, namely, dynamic CTA (computed tomography angiography), on an endovascular device. To our knowledge, this new approach will yield new in vivo data on endograft behavior.
This pilot study aims to quantitatively characterize the stresses and forces on an implanted endograft during the cardiac cycle in patients scheduled for standard endograft follow-up. In addition, in order to have the possibility to compare the movement of the aorta pre- and post-endograft placement, the aorta of patients planned for an endograft implantation procedure and who are thus already planned to undergo a clinical CT will also instead be scanned using ECG gated dynamic CTprotocol.
The developed techniques will be applied in future studies for characterizing and comparing the currently commercially available endografts so as to gain insight into the mechanisms underlying potential endograft failure, and in addition, to assist in developing endografts with long-term durability and functioning characteristics for the benefit of the patient.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00680004
|Contact: Leo Schultze Kool, MDfirstname.lastname@example.org|
|Contact: Jan Blankensteijn, MD||+31243615333||J.Blankensteijn@CHIR.umcn.nl|
|UMC St Radboud||Recruiting|
|Nijmegen, Netherlands, 6525GA|
|Contact: Leo Schultze Kool email@example.com|
|Principal Investigator: Leo Schultze Kool, MD, PhD|
|Sub-Investigator: KJ Renema, PhD|
|Principal Investigator:||Leo Schultze Kool, MD||UMC St Radboud Nijmegen|