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DynaCT in Preoperative Imaging Before Insertion of Stentgraft

NCT ID: NCT01146639

Last Updated: 2017-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-08-31

Study Completion Date

2010-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Abdominal Aortic Aneurysm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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MDCT and additional DynaCT

Group Type EXPERIMENTAL

DynaCT

Intervention Type RADIATION

One extra set of images with DynaCT including one extra injection of contrast medium.

Iodixanol

Intervention Type DRUG

One extra set of images with DynaCT including one extra injection of 50 ml contrast medium.

Interventions

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DynaCT

One extra set of images with DynaCT including one extra injection of contrast medium.

Intervention Type RADIATION

Iodixanol

One extra set of images with DynaCT including one extra injection of 50 ml contrast medium.

Intervention Type DRUG

Other Intervention Names

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Visipaque Amersham Health 270 mg I/ml

Eligibility Criteria

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Inclusion Criteria

* Not inserted stent graft before.
* Patiens over 60 Years old.
* Able to give informed consent.

Exclusion Criteria

\-
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Norwegian University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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St Olavs Hospital, Operating Room of the Future.

Trondheim, , Norway

Site Status

Countries

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Norway

References

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Eide KR, Odegard 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. Epub 2011 Jul 22.

Reference Type RESULT
PMID: 21782483 (View on PubMed)

Other Identifiers

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rek 4.2008.802

Identifier Type: -

Identifier Source: org_study_id

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