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Aortic AneurysmNCT00680004

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

An observational study of Aortic Aneurysm, run by Radboud University Medical Center at 1 site in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Aortic Aneurysm
How many people
40 participants
Where
1 siteNetherlands
Study dates
Jan 2007to Dec 2009
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • Known allergy for contrast medium

Trial locations and contacts

1 site in 1 country.

Leo Schultze Kool, MD contact

+31243614546

l.schultzekool@rad.umcn.nl

Jan Blankensteijn, MD contact

+31243615333

J.Blankensteijn@CHIR.umcn.nl

Netherlands1 site, 1 recruiting
  • UMC St Radboud

    Nijmegen, 6525GA

    Leo Schultze Kool, l.schultzekool@rad.umcn.nl

    Leo Schultze Kool, MD, PhD

    Recruiting

Other trials in Netherlands

About this study

Official title: The Value of Dynamic CTA During the Follow-up of EndoVascular Aortic Replacement (EVAR): a Pilot Study

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

Read the 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.

Conditions
Aortic Aneurysm
Keywords
Dynamic CTA, follow-up, EVAR
Medical subject headings
Aortic Aneurysm

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00680004
Study groupRoleWhat they receive
1Preoperative patients planned for a CT prior to an endograft implantation procedure
2Patients who underwent a complicated endograft implant and/or with increased risk of complications

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. to quantitatively characterize the stresses and forces on an implanted endograft during the cardiac cycle in terms of longitudinal movement

Secondary outcomes (1)
  1. 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 May 2008 (estimated)
  2. Study startJan 2007
  3. Primary completionSep 2008 (estimated)
  4. Study completionDec 2009 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00680004
Sponsor's protocol ID
dCTA-2006-YH
Status last verified
May 2008
First submitted
15 May 2008
Last updated
19 May 2008
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

An observational study of Aortic Aneurysm, run by Radboud University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 May 2008. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Leo Schultze Kool, MD (+31243614546, l.schultzekool@rad.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

to quantitatively characterize the stresses and forces on an implanted endograft during the cardiac cycle in terms of longitudinal movement. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2008.

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