Back to resultsDynaCT in Preoperative Imaging Before Insertion of Stentgraft (DynaCT)
Primary Purpose
Abdominal Aortic Aneurysm
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
DynaCT
Iodixanol
Sponsored by
About this trial
This is an interventional diagnostic trial for Abdominal Aortic Aneurysm focused on measuring EVAR DynaCT
Eligibility Criteria
Inclusion Criteria:
- Not inserted stent graft before.
- Patiens over 60 Years old.
- Able to give informed consent.
Exclusion Criteria: Not
-
Sites / Locations
- St Olavs Hospital, Operating Room of the Future.
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
MDCT and additional DynaCT
Arm Description
Outcomes
Primary Outcome Measures
Verify clinical usefulness of DynaCT images in preoperative imaging.
Secondary Outcome Measures
Full Information
NCT ID
NCT01146639
First Posted
June 16, 2010
Last Updated
January 16, 2017
Sponsor
Norwegian University of Science and Technology
1. Study Identification
Unique Protocol Identification Number
NCT01146639
Brief Title
DynaCT in Preoperative Imaging Before Insertion of Stentgraft
Acronym
DynaCT
Official Title
Usefulness of DynaCT Compared to Multidetector CT as Preoperative Imaging Before Insertion of Aortic Stentgraft.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm
Keywords
EVAR DynaCT
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MDCT and additional DynaCT
Arm Type
Experimental
Intervention Type
Radiation
Intervention Name(s)
DynaCT
Intervention Description
One extra set of images with DynaCT including one extra injection of contrast medium.
Intervention Type
Drug
Intervention Name(s)
Iodixanol
Other Intervention Name(s)
Visipaque Amersham Health 270 mg I/ml
Intervention Description
One extra set of images with DynaCT including one extra injection of 50 ml contrast medium.
Primary Outcome Measure Information:
Title
Verify clinical usefulness of DynaCT images in preoperative imaging.
Time Frame
One year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Not inserted stent graft before.
Patiens over 60 Years old.
Able to give informed consent.
Exclusion Criteria: Not
-
Facility Information:
Facility Name
St Olavs Hospital, Operating Room of the Future.
City
Trondheim
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
21782483
Citation
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.
Results Reference
result
Learn more about this trial
DynaCT in Preoperative Imaging Before Insertion of Stentgraft
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