Comparing Fluoroscopy and Technological Methods for Guidance During Endovascular Procedures

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

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).

Sponsors & Collaborators

• SINTEF Health Research

  collaborator OTHER

• St. Olavs Hospital

  collaborator OTHER

• The Research Council of Norway

  collaborator OTHER

• Norwegian University of Science and Technology

  lead OTHER

Principal Investigators

• Frode Manstad-Hulaas, MD · Norwegian University of Science and Technology

• Petter Aadahl, Professor · Norwegian University of Science and Technology

• Toril N Hernes, Professor · SINTEF Health Research

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2007-08-31

Primary Completion

2010-01-31

Completion

2010-04-30

Countries

• Norway

Study Locations