NCT00355940

Comparing Fluoroscopy and Technological Methods for Guidance During Endovascular Procedures

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 17 (actual)
• Sponsor: Norwegian University of Science and Technology · Academic / Other
• Sex: All
• Age: 60 Years
• Healthy volunteers: Not accepted

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

Conditions

• Aortic Aneurysm, Abdominal

Interventions

Type	Name	Description
DEVICE	Technological Methods	Usage of technological methods and devices to improve intravascular navigation during endovascular aortic repair. In this arm we first use an optical pointer to allocate the femoral artery ramification (point of incision) and the lower renal artery (upper confinement of stent graft). Later we use an electromagnetically tracked catheter to find and enter the opening in the main stent graft before placing the second limb. For both optical and electromagnetic tracking we use a custom made navigation system based on 3 dimensional CT images
DEVICE	Regular Fluoroscopy	Usage of conventional fluoroscopy and angiography for intravascular navigation. In this arm standard endovascular aortic repair is performed. The only means of navigation are fluoroscopy and angiography with overlay function (standard).

Timeline

• Start date: 2007-08-01
• Primary completion: 2010-01-01
• Completion: 2010-04-01
• First posted: 2006-07-25
• Last updated: 2013-04-29

Locations

1 site across 1 country: Norway