Comparing Fluoroscopy and Technological Methods for Guidance During Endovascular Procedures

Aortic Aneurysm, Abdominal Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00355940
• Other study ID #: STO-NTNU/DMF-SINTEF-1
• Status: Completed
• Phase: Phase 1
• First received: July 24, 2006
• Last updated: April 26, 2013
• Start date: August 2007
• Est. completion date: April 2010

Study information

• Verified date: April 2013
• Source: Norwegian University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: April 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 60 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Aortic Aneurysm
• Aortic Aneurysm, Abdominal

Intervention

Device:
• Technological 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
• Regular 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).

Locations

Country	Name	City	State
Norway	St Olavs Hospital	Trondheim

Sponsors (4)

Lead Sponsor	Collaborator
Norwegian University of Science and Technology	SINTEF Health Research, St. Olavs Hospital, The Research Council of Norway

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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: 10.1583/11-355 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measure time (s) for defining renal branch		No time frame	No
Primary	Measure time (s) for inserting guidewire into "second limb"		900 sec	No
Primary	Number of attempts for inserting guidewire into "second limb"		900 sec	No
Primary	Measure total time (min) for entire procedure		No time frame	No
Primary	Measure the total of x-ray dose (mGy/m2)		No time frame	No
Primary	Measure the total of contrast fluid used (ml)		No time frame	No
Primary	Define type I leak between stent graft and aortic wall		No time frame	No
Primary	Measure distance (mm) between stent graft and renal arteries		No time frame	No
Primary	Measure difference (mm) in actual position and position in 3D image when pointing at the femoral division with an optic pointer		No time frame	No
Primary	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	No
Secondary	1 questionnaire: "Can 3D image and navigation technology simplify and secure endovascular procedures?"		No time frame	No
Secondary	2 questionnaire: "Do you believe in further development of this technology?"		No time frame	No
Secondary	3 questionnaire: "Have both renal arteries unaltered flow?"		No time frame	No