Comparing Fluoroscopy and Technological Methods for Guidance During Endovascular Procedures

Study Overview
=================
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

Official Title
-----------------
Comparing Fluoroscopy and Technological Methods for Guidance During Endovascular Procedures Traditional Fluoroscopy Navigation Based on Preoperative CT and Intraoperative DynaCT

Conditions
-----------------
Aortic Aneurysm, Abdominal

Intervention / Treatment
-----------------
* Device: Technological Methods
* Device: Regular Fluoroscopy


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: Technological Methods<br>* 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<br>* Other names: Custom made devices in addition to Siemens angiography suite;|
| Active Comparator: 2<br> | Device: Regular Fluoroscopy<br>* 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).<br>* Other names: Siemens angiography suite;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 3 questionnaire: Have both renal arteries unaltered flow? |  | No time frame | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endovascular, aortic, repair, navigation, DynaCT, position, sensor