Comparing Fluoroscopy and Technological Methods for Guidance During Endovascular Procedures

Phase 1

Completed

• Conditions: Aortic Aneurysm, Abdominal
• Interventions: Device: Technological Methods; Device: Regular Fluoroscopy

• Registration Number: NCT00355940
• Lead Sponsor: Norwegian University of Science and Technology

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-07-24
• Study First Submitted QC: 2006-07-24
• Study First Posted: 2006-07-25
• Study Start: 2007-08
• Primary Completion: 2010-01
• Study Completion: 2010-04
• Status Verified: 2013-04
• Last Update Submitted: 2013-04-26
• Last Update Posted: 2013-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Technological Methods	-
2	Regular Fluoroscopy	-

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

St Olavs Hospital; 🇳🇴 Trondheim, Norway