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| Name | Class |
|---|---|
| SINTEF Health Research | OTHER |
| St. Olavs Hospital | OTHER |
| The Research Council of Norway | OTHER |
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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):
Alternative hypothesis (H2):
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Technological Methods | Device | 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 |
| Measure | Description | 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 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 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frode Manstad-Hulaas, MD | Norwegian University of Science and Technology | Principal Investigator |
| Petter Aadahl, Professor | Norwegian University of Science and Technology | Study Director |
| Toril N Hernes, Professor | SINTEF Health Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Olavs Hospital | Trondheim | 7006 | Norway |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22313205 | Result | Manstad-Hulaas F, Tangen GA, Dahl T, Hernes TA, Aadahl P. Three-dimensional electromagnetic navigation vs. fluoroscopy for endovascular aneurysm repair: a prospective feasibility study in patients. J Endovasc Ther. 2012 Feb;19(1):70-8. doi: 10.1583/11-3557.1. |
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| ID | Term |
|---|---|
| D017544 | Aortic Aneurysm, Abdominal |
| ID | Term |
|---|---|
| D001014 | Aortic Aneurysm |
| D000783 | Aneurysm |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| Regular Fluoroscopy | Device | 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). |
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| 3 questionnaire: "Have both renal arteries unaltered flow?" | No time frame |
| D001018 |
| Aortic Diseases |