Clinical trial NCT00355940: Comparing Fluoroscopy and Technological Methods for Guidance During Endovascular Procedures
Official title: Comparing Fluoroscopy and Technological Methods for Guidance During Endovascular Procedures Traditional Fluoroscopy Navigation Based on Preoperative CT and Intraoperative DynaCT
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Aortic Aneurysm, Abdominal
Keywords: endovascular
aortic
repair
navigation
DynaCT
position
sensor
Lead sponsor: Norwegian University of Science and Technology
Sponsor class: OTHER
Collaborators: name: SINTEF Health Research
name: St. Olavs Hospital
name: The Research Council of Norway
First posted: 2006-07-25
Enrollment: 17
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Measure time (s) for defining renal branch
timeFrame: No time frame
measure: Measure time (s) for inserting guidewire into "second limb"
timeFrame: 900 sec
measure: Number of attempts for inserting guidewire into "second limb"
timeFrame: 900 sec
measure: Measure total time (min) for entire procedure
timeFrame: No time frame
measure: Measure the total of x-ray dose (mGy/m2)
timeFrame: No time frame
measure: Measure the total of contrast fluid used (ml)
timeFrame: No time frame
measure: Define type I leak between stent graft and aortic wall
timeFrame: No time frame
measure: Measure distance (mm) between stent graft and renal arteries
timeFrame: No time frame
measure: Measure difference (mm) in actual position and position in 3D image when pointing at the femoral division with an optic pointer
timeFrame: No time frame
measure: Measure difference (mm) of the position of the renal arteries defined by optical pointer and angiography (both marked extracorporal with a needle)
timeFrame: No time frame
Secondary outcomes:
measure: 1 questionnaire: "Can 3D image and navigation technology simplify and secure endovascular procedures?"
timeFrame: No time frame
measure: 2 questionnaire: "Do you believe in further development of this technology?"
timeFrame: No time frame
measure: 3 questionnaire: "Have both renal arteries unaltered flow?"
timeFrame: No time frame
Other outcomes:
Locations:
city: Trondheim
country: Norway
facility: St Olavs Hospital
Study officials:
affiliation: Norwegian University of Science and Technology
name: Frode Manstad-Hulaas, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Norwegian University of Science and Technology
name: Petter Aadahl, Professor
role: STUDY_DIRECTOR
affiliation: SINTEF Health Research
name: Toril N Hernes, Professor
role: STUDY_DIRECTOR
References:
citation: 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.