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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01146639
Other study ID # rek 4.2008.802
Secondary ID
Status Completed
Phase N/A
First received June 16, 2010
Last updated January 16, 2017
Start date August 2008
Est. completion date June 2010

Study information

Verified date January 2017
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Endovascular therapy of Aortic Aneurysms depends on good imaging facilities. A relatively new kind of x-ray equipment makes it possible to create computer tomography (CT) - like slice images in the operating room. The purpose of this study is to verify the clinical usefulness of DynaCT in a preoperative setting. To do so we compare aortic measurements in DynaCT to the same measurements in ordinary CT-images which are regarded the gold standard.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date June 2010
Est. primary completion date May 2010
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility Inclusion Criteria:

- Not inserted stent graft before.

- Patiens over 60 Years old.

- Able to give informed consent.

Exclusion Criteria: Not

Study Design


Intervention

Radiation:
DynaCT
One extra set of images with DynaCT including one extra injection of contrast medium.
Drug:
Iodixanol
One extra set of images with DynaCT including one extra injection of 50 ml contrast medium.

Locations

Country Name City State
Norway St Olavs Hospital, Operating Room of the Future. Trondheim

Sponsors (1)

Lead Sponsor Collaborator
Norwegian University of Science and Technology

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Eide KR, Ødegård A, Myhre HO, Hatlinghus S, Haraldseth O. DynaCT in pre-treatment evaluation of aortic aneurysm before EVAR. Eur J Vasc Endovasc Surg. 2011 Sep;42(3):332-9. doi: 10.1016/j.ejvs.2011.05.014. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Verify clinical usefulness of DynaCT images in preoperative imaging. One year
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