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

Primary Purpose

Abdominal Aortic Aneurysm

Status

Completed

Phase

Not Applicable

Locations

Norway

Study Type

Interventional

Intervention

DynaCT

About this trial

This is an interventional diagnostic trial for Abdominal Aortic Aneurysm

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age over 65, Satisfactory renal function

Sites / Locations

St. Olavs Hosptial

Outcomes

Primary Outcome Measures

Evidence og clinical benefit of new imaging functionality.

Secondary Outcome Measures

Full Information

NCT ID

NCT00264862

First Posted

December 12, 2005

Last Updated

February 27, 2014

Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00264862

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2014

Overall Recruitment Status

Completed

Study Start Date

December 2005 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

March 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Norwegian University of Science and Technology

Collaborators

St. Olavs Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Abdominal Aortic Aneurysm

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Procedure

Intervention Name(s)

DynaCT

Primary Outcome Measure Information:

Title

Evidence og clinical benefit of new imaging functionality.

Time Frame

3 days (pluss or minus 3 days).

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age over 65, Satisfactory renal function

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kari R Eide, MS

Organizational Affiliation

NTNU/St.Olavs Hospital

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Olav Haraldseth, PhD MD

Organizational Affiliation

National Taiwan Normal University

Official's Role

Study Chair

Facility Information:

Facility Name

St. Olavs Hosptial

City

Trondheim

ZIP/Postal Code

7006

Country

Norway

12. IPD Sharing Statement

Citations:

PubMed Identifier

19010697

Citation

Eide KR, Odegard 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.

Results Reference

result

Learn more about this trial

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

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