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

Study Overview

• Status: Completed
• Conditions: Aortic Aneurysm, Abdominal
• Intervention / Treatment: Device: Technological Methods; Device: Regular Fluoroscopy

• Study Type: Interventional
• Enrollment (Actual): 17
• Phase: Phase 1

Contacts and Locations

Study Locations

• Norway
  • Trondheim, Norway, 7006
    • St Olavs Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	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; Other Names: Custom made devices in addition to Siemens angiography suite
Active Comparator: 2	Device: 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).; Other Names: Siemens angiography suite

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Norwegian University of Science and Technology
• Collaborators: The Research Council of Norway; St. Olavs Hospital; SINTEF Health Research
• Investigators: 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

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2007
• Primary Completion (Actual): January 1, 2010
• Study Completion (Actual): April 1, 2010

Study Registration Dates

• First Submitted: July 24, 2006
• First Submitted That Met QC Criteria: July 24, 2006
• First Posted (Estimate): July 25, 2006

Study Record Updates

• Last Update Posted (Estimate): April 29, 2013
• Last Update Submitted That Met QC Criteria: April 26, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: position; endovascular; aortic; repair; navigation; DynaCT; sensor
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Aortic Diseases; Aneurysm; Aortic Aneurysm; Aortic Aneurysm, Abdominal
• Other Study ID Numbers: STO-NTNU/DMF-SINTEF-1