Aortic Aneurysm, Abdominal
Conditions
Keywords
endovascular, aortic, repair, navigation, DynaCT, position, sensor
Brief 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
Interventions
DEVICETechnological 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
DEVICERegular 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
SINTEF Health Research
St. Olavs Hospital
The Research Council of Norway
Norwegian University of Science and Technology
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* AAA with diameter \> 5,0 cm suitable for endovascular technique * Normal creatinine * \> 60 years of age
Exclusion criteria
* Known heart failure or unstable coronary disease * Other morbidity than normally contraindicates endovascular treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measure the total of x-ray dose (mGy/m2) | No time frame |
| Measure the total of contrast fluid used (ml) | No time frame |
| Define type I leak between stent graft and aortic wall | No time frame |
| Measure time (s) for defining renal branch | No time frame |
| Measure time (s) for inserting guidewire into second limb | 900 sec |
| Number of attempts for inserting guidewire into second limb | 900 sec |
| Measure total time (min) for entire procedure | No time frame |
| Measure distance (mm) between stent graft and renal arteries | No time frame |
| Measure difference (mm) in actual position and position in 3D image when pointing at the femoral division with an optic pointer | No time frame |
| Measure difference (mm) of the position of the renal arteries defined by optical pointer and angiography (both marked extracorporal with a needle) | No time frame |
Secondary
| Measure | Time frame |
|---|---|
| 1 questionnaire: Can 3D image and navigation technology simplify and secure endovascular procedures? | No time frame |
| 2 questionnaire: Do you believe in further development of this technology? | No time frame |
| 3 questionnaire: Have both renal arteries unaltered flow? | No time frame |
Countries
Norway
Outcome results
None listed