NCT01146639

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 17, 2010

Completed
Last Updated

January 18, 2017

Status Verified

January 1, 2017

Enrollment Period

1.7 years

First QC Date

June 16, 2010

Last Update Submit

January 16, 2017

Conditions

Abdominal Aortic Aneurysm

Keywords

EVAR DynaCT

Outcome Measures

Primary Outcomes (1)

  • Verify clinical usefulness of DynaCT images in preoperative imaging.

    One year

Study Arms (1)

MDCT and additional DynaCT

EXPERIMENTAL
Radiation: DynaCTDrug: Iodixanol

Interventions

DynaCTRADIATION

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

MDCT and additional DynaCT
IodixanolDRUG

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

Also known as: Visipaque Amersham Health 270 mg I/ml
MDCT and additional DynaCT

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Olavs Hospital, Operating Room of the Future.

Trondheim, Norway

Location

Related Publications (1)

  • 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.

    PMID: 21782483RESULT

MeSH Terms

Conditions

Aortic Aneurysm, Abdominal

Interventions

iodixanol

Condition Hierarchy (Ancestors)

Aortic AneurysmAneurysmVascular DiseasesCardiovascular DiseasesAortic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2010

First Posted

June 17, 2010

Study Start

August 1, 2008

Primary Completion

May 1, 2010

Study Completion

June 1, 2010

Last Updated

January 18, 2017

Record last verified: 2017-01

Locations

NO(1)