Dynamic Computed Tomography Angiography (CTA) Follow-up for EndoVascular Aortic Replacement (EVAR)
Recruitment status was Recruiting
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | May 15, 2008 | ||||||||
| Last Updated Date | May 16, 2008 | ||||||||
| Start Date ICMJE | January 2007 | ||||||||
| Estimated Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT00680004 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Dynamic Computed Tomography Angiography (CTA) Follow-up for EndoVascular Aortic Replacement (EVAR) | ||||||||
| Official Title ICMJE | The Value of Dynamic CTA During the Follow-up of EndoVascular Aortic Replacement (EVAR): a Pilot Study | ||||||||
| Brief Summary | 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 |
||||||||
| 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. |
||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| 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. |
||||||||
| Condition ICMJE | Aortic Aneurysm | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 40 | ||||||||
| Estimated Completion Date | December 2009 | ||||||||
| Estimated Primary Completion Date | September 2008 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | Netherlands | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT00680004 | ||||||||
| Other Study ID Numbers ICMJE | dCTA-2006-YH | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | Professor Leo Schultze Kool, UMC St Radboud Nijmegen | ||||||||
| Study Sponsor ICMJE | Radboud University | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Radboud University | ||||||||
| Verification Date | May 2008 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||