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NCT00264862 Clinical Trial

DynaCT Imaging in EVAR: Comparing Clinical Benefit of DynaCT to Multidetector CT as the Current Gold Standard.

Abdominal Aortic Aneurysm Clinical Trial

Official title:
Use of DynaCT in Endovascular Treatment of Abdominal Aortic Aneurysm. Evaluation of Image Quality.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00264862
Other study ID # FOR2008_1
Secondary ID
Status Completed
Phase N/A
First received December 12, 2005
Last updated February 27, 2014
Start date December 2005
Est. completion date March 2007

Study information
Verified date February 2014
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Social Science Data Services
Study type Interventional

Clinical Trial Summary

The aim of this study is to evaluate a new way to create CT-like images during intra-operative procedures. We want to prove that the quality and information received from DynaCT is satisfactory in implementing stent-graft in abdominal aortic aneurysm.

Description:

The study will compare images from the new modality (DynaCT) with the present modality (Multi detectorCT). We make three different set of images from each modality.

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date March 2007
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 65 Years and older
Eligibility Inclusion Criteria:

- Age over 65,

- Satisfactory renal function

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

Intervention

Procedure:
• DynaCT

Locations
Country Name City State
Norway St. Olavs Hosptial Trondheim

Sponsors (2)
Lead Sponsor Collaborator
Norwegian University of Science and Technology St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Eide KR, Ødegård A, Myhre HO, Lydersen S, Hatlinghus S, Haraldseth O. DynaCT during EVAR--a comparison with multidetector CT. Eur J Vasc Endovasc Surg. 2009 Jan;37(1):23-30. doi: 10.1016/j.ejvs.2008.09.017. Epub 2008 Nov 17. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Evidence og clinical benefit of new imaging functionality. 3 days (pluss or minus 3 days).
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