| July 24, 2006 |
| November 3, 2008 |
| August 2007 |
| January 2009 (final data collection date for primary outcome measure) |
- Measure time (s) for defining renal branch [ Time Frame: No time frame ] [ Designated as safety issue: No ]
- Measure time (s) for inserting guidewire into "second limb" [ Time Frame: 900 sec ] [ Designated as safety issue: No ]
- Number of attempts for inserting guidewire into "second limb" [ Time Frame: 900 sec ] [ Designated as safety issue: No ]
- Measure total time (min) for entire procedure [ Time Frame: No time frame ] [ Designated as safety issue: No ]
- Measure the total of x-ray dose (mGy/m2) [ Time Frame: No time frame ] [ Designated as safety issue: No ]
- Measure the total of contrast fluid used (ml) [ Time Frame: No time frame ] [ Designated as safety issue: No ]
- Define type I leak between stent graft and aortic wall [ Time Frame: No time frame ] [ Designated as safety issue: No ]
- Measure distance (mm) between stent graft and renal arteries [ Time Frame: No time frame ] [ Designated as safety issue: No ]
- Measure difference (mm) in actual position and position in 3D image when pointing at the femoral division with an optic pointer [ Time Frame: No time frame ] [ Designated as safety issue: No ]
- Measure difference (mm) of the position of the renal arteries defined by optical pointer and angiography (both marked extracorporal with a needle) [ Time Frame: No time frame ] [ Designated as safety issue: No ]
|
- Measure time (s) for defining renal branch
- Measure time (s) for inserting guidewire into "second limb"
- Number of attempts for inserting guidewire into "second limb"
- Measure total time (min) for entire procedure
- Measure the total of x-ray dose (mGy/m2)
- Measure the total of contrast fluid used (ml)
- Define type I leak between stentgraft and aortic wall
- Measure distance (mm) between stentgraft and renal arteries
- Measure difference (mm) in actual position and position in 3D image when pointing at the femoral division with an optic pointer
- Measure difference (mm) of the position of the renal arteries defined by optical poiner and angiography (both marked extracoporal with a needle)
|
| Complete list of historical versions of study NCT00355940 on ClinicalTrials.gov Archive Site |
- 1 questionnaire: "Can 3D image and navigation technology simplify and secure endovascular procedures?" [ Time Frame: No time frame ] [ Designated as safety issue: No ]
- 2 questionnaire: "Do you believe in further development of this technology?" [ Time Frame: No time frame ] [ Designated as safety issue: No ]
- 3 questionnaire: "Have both renal arteries unaltered flow?" [ Time Frame: No time frame ] [ Designated as safety issue: No ]
|
- 1 questionnaire: "Can 3D image and navigation technology simplify and secure endovascular procedures?"
- 2 questionnaire: "Do you belive in further development of this technology?"
- 3 questionnaire: "Have both renal arteries unaltered flow?"
|
| |
| 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 |
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
|
| |
| Phase I |
| Interventional |
| Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Aortic Aneurysm, Abdominal |
- Device: Technological Methods
- Device: Regular Fluoroscopy
|
| |
| |
| |
| Recruiting |
| 20 |
| July 2009 |
| January 2009 (final data collection date for primary outcome measure) |
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
|
| Both |
| 60 Years and older |
| No |
|
|
| Norway |
| |
| NCT00355940 |
| Frode Manstad-Hulaas, Norwegian University of Science and Technology |
| STO-NTNU/DMF-SINTEF-1 |
| Norwegian University of Science and Technology |
- SINTEF Health Research
- St. Olavs Hospital
- The Research Council of Norway
|
| Principal Investigator: |
Frode Manstad-Hulaas, MD |
Norwegian University of Science and Technology |
|
| Study Director: |
Petter Aadahl, Professor |
Norwegian University of Science and Technology |
|
| Study Director: |
Toril N Hernes, Professor |
SINTEF Health Research |
|
|
| Norwegian University of Science and Technology |
| November 2008 |
