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DynaCT in Preoperative Imaging Before Insertion of Stentgraft

This study has been completed.
Sponsor:
Information provided by:
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT01146639
First received: June 16, 2010
Last updated: June 17, 2010
Last verified: June 2010
  Purpose

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.


Condition Intervention
Abdominal Aortic Aneurysm
Radiation: DynaCT
Drug: Iodixanol

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Usefulness of DynaCT Compared to Multidetector CT as Preoperative Imaging Before Insertion of Aortic Stentgraft.

Resource links provided by NLM:


Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:
  • Verify clinical usefulness of DynaCT images in preoperative imaging. [ Time Frame: One year ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: August 2008
Study Completion Date: June 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    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.
    Other Name: Visipaque Amersham Health 270 mg I/ml
  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria: Not

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  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01146639

Locations
Norway
St Olavs Hospital, Operating Room of the Future.
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
  More Information

No publications provided

Responsible Party: Professor Olav Haraldseth, NTNU, Faculty of Medicine, Department of circulation and medical imaging
ClinicalTrials.gov Identifier: NCT01146639     History of Changes
Other Study ID Numbers: rek 4.2008.802
Study First Received: June 16, 2010
Last Updated: June 17, 2010
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:
EVAR DynaCT

Additional relevant MeSH terms:
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Aneurysm
Aortic Diseases
Cardiovascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 25, 2014