Dynamic Computed Tomography Angiography (CTA) Follow-up for EndoVascular Aortic Replacement (EVAR)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2008 by Radboud University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00680004
First received: May 15, 2008
Last updated: May 16, 2008
Last verified: May 2008
  Purpose

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. 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. In addition, to assist in developing endografts with long-term durability and functioning characteristics for the benefit of the patient


Condition
Aortic Aneurysm

Study Type: Observational
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

Resource links provided by NLM:


Further study details as provided by Radboud University:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 40
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)
Groups/Cohorts
1
Preoperative patients planned for a CT prior to an endograft implantation procedure
2
Patients who underwent a complicated endograft implant and/or with increased risk of complications

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients undergoing either a preoperative CT procedure or with an implanted aortic endoprothesis (-graft) presenting to the department of radiology for a scheduled follow-up CTA procedure.

Criteria

Inclusion Criteria:

  • 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
  • 18 years of age or older
  • Patients who have given their informed consent

Exclusion Criteria:

  • Known allergy for contrast medium
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00680004

Contacts
Contact: Leo Schultze Kool, MD +31243614546 l.schultzekool@rad.umcn.nl
Contact: Jan Blankensteijn, MD +31243615333 J.Blankensteijn@CHIR.umcn.nl

Locations
Netherlands
UMC St Radboud Recruiting
Nijmegen, Netherlands, 6525GA
Contact: Leo Schultze Kool       l.schultzekool@rad.umcn.nl   
Principal Investigator: Leo Schultze Kool, MD, PhD         
Sub-Investigator: KJ Renema, PhD         
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Leo Schultze Kool, MD UMC St Radboud Nijmegen
  More Information

No publications provided

Responsible Party: Professor Leo Schultze Kool, UMC St Radboud Nijmegen
ClinicalTrials.gov Identifier: NCT00680004     History of Changes
Other Study ID Numbers: dCTA-2006-YH
Study First Received: May 15, 2008
Last Updated: May 16, 2008
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Radboud University:
Dynamic CTA
follow-up
EVAR

Additional relevant MeSH terms:
Aortic Aneurysm
Aneurysm
Aortic Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on October 21, 2014