Comparing Fluoroscopy and Technological Methods for Guidance During Endovascular Procedures - Full Text View

Purpose

We 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 wich 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

Condition	Intervention	Phase
Aortic Aneurysm, Abdominal	Device: Technological Methods Device: Regular Fluoroscopy	Phase I

MedlinePlus related topics:

Aneurysms

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

Further study details as provided by Norwegian University of Science and Technology:

Primary Outcome Measures:

Measure time (s) for defining renal branch [ Time Frame: No time frame ] [ Designated as safety issue: No ]
Measure time (s) for inserting guidewire into "second limb" [ Time Frame: 900 sec ] [ Designated as safety issue: No ]
Number of attempts for inserting guidewire into "second limb" [ Time Frame: 900 sec ] [ Designated as safety issue: No ]
Measure total time (min) for entire procedure [ Time Frame: No time frame ] [ Designated as safety issue: No ]
Measure the total of x-ray dose (mGy/m2) [ Time Frame: No time frame ] [ Designated as safety issue: No ]
Measure the total of contrast fluid used (ml) [ Time Frame: No time frame ] [ Designated as safety issue: No ]
Define type I leak between stent graft and aortic wall [ Time Frame: No time frame ] [ Designated as safety issue: No ]
Measure distance (mm) between stent graft and renal arteries [ Time Frame: No time frame ] [ Designated as safety issue: No ]
Measure difference (mm) in actual position and position in 3D image when pointing at the femoral division with an optic pointer [ Time Frame: No time frame ] [ Designated as safety issue: No ]
Measure difference (mm) of the position of the renal arteries defined by optical pointer and angiography (both marked extracorporal with a needle) [ Time Frame: No time frame ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

1 questionnaire: "Can 3D image and navigation technology simplify and secure endovascular procedures?" [ Time Frame: No time frame ] [ Designated as safety issue: No ]
2 questionnaire: "Do you believe in further development of this technology?" [ Time Frame: No time frame ] [ Designated as safety issue: No ]
3 questionnaire: "Have both renal arteries unaltered flow?" [ Time Frame: No time frame ] [ Designated as safety issue: No ]

Estimated Enrollment:	20
Study Start Date:	August 2007
Estimated Study Completion Date:	July 2009
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Device: Technological Methods Usage of technological methods and devices to improve intravascular navigation during endovascular aortic repair.
2: Active Comparator	Device: Regular Fluoroscopy Usage of conventional fluoroscopy and angiography for intravascular navigation.

Eligibility

Ages Eligible for Study:	60 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00355940

Contacts


Contact: Frode Manstad-Hulaas, MD	+47 73 86 86 60	frode.manstad-hulaas@stolav.no

Contact: Petter Aadahl, MD Professor	+47 73 86 94 72	petter.aadahl@medisin.ntnu.no

Locations


Norway
	St Olavs Hospital	Recruiting
	Trondheim, Norway, 7006
	Contact: Frode Manstad-Hulaas, MD +47 92826630 frode.manstad-hulaas@stolav.no
	Principal Investigator: Frode Manstad-Hulaas, MD

Sponsors and Collaborators

Norwegian University of Science and Technology

SINTEF Health Research

St. Olavs Hospital

The Research Council of Norway

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

More Information

Responsible Party:	Norwegian University of Science and Technology ( Frode Manstad-Hulaas )
Study ID Numbers:	STO-NTNU/DMF-SINTEF-1
First Received:	July 24, 2006
Last Updated:	May 6, 2008
ClinicalTrials.gov Identifier:	NCT00355940
Health Authority:	Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:

endovascular

aortic

repair

navigation

DynaCT

position

sensor

Study placed in the following topic categories:

Aortic Diseases

Aneurysm

Aortic Aneurysm, Abdominal

Abdominal aortic aneurysm

Vascular Diseases

Aortic Aneurysm

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 05, 2008

Sponsors and Collaborators:	Norwegian University of Science and Technology SINTEF Health Research St. Olavs Hospital The Research Council of Norway
Information provided by:	Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:	NCT00355940