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Comparing Fluoroscopy and Technological Methods for Guidance During Endovascular Procedures

Aortic Aneurysm, Abdominal Clinical Trial

Official title:
Comparing Fluoroscopy and Technological Methods for Guidance During Endovascular Procedures Traditional Fluoroscopy Navigation Based on Preoperative CT and Intraoperative DynaCT

Clinical Trial Summary

The investigators want to test a navigation system for guidance during insertion of stent graft in abdominal aortic aneurysms. The navigation system consists of software developed by SINTEF Health, a custom made catheter with a micro position sensor in the tip and an emitter than induces an electromagnetic field around the patient. Preoperative CT- and intraoperative DynaCT- data are reconstructed into 3 dimensional images. The 3 dimensional images are loaded into the navigation system. Then the magnetic field, in which the patient finds himself, is calibrated with the 3 dimensional images. When the catheter is inserted into the iliac artery and aorta, the position sensor (in the tip of the catheter) is displayed in real time at the exact anatomic location in the 3 dimensional image.

Null hypothesis (H0):

- Insertion of stent graft is performed equally satisfactorily with fluoroscopy alone as with both fluoroscopy and new navigation technology

Alternative hypothesis (H2):

- Insertion of stent graft is NOT performed equally satisfactorily with fluoroscopy alone as with both fluoroscopy and new navigation technology

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00355940
Study type Interventional
Source Norwegian University of Science and Technology
Contact
Status Completed
Phase Phase 1
Start date August 2007
Completion date April 2010
View Details
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