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

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

Purpose

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

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

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

Resource links provided by NLM:

MedlinePlus related topics: Aneurysms Aortic Aneurysm

U.S. FDA Resources

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. 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 stentgraft). 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
2: Active Comparator	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).

Arms

Assigned Interventions

1: Experimental

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 stentgraft). 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

2: Active Comparator

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).

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

No publications provided

Responsible Party:	Norwegian University of Science and Technology ( Frode Manstad-Hulaas )
Study ID Numbers:	STO-NTNU/DMF-SINTEF-1
Study First Received:	July 24, 2006
Last Updated:	November 3, 2008
ClinicalTrials.gov Identifier:	NCT00355940 History of Changes
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

Vascular Diseases
Aortic Aneurysm
Abdominal Aortic Aneurysm

Additional relevant MeSH terms:

Aortic Diseases
Aneurysm
Aortic Aneurysm, Abdominal

Vascular Diseases
Cardiovascular Diseases
Aortic Aneurysm

ClinicalTrials.gov processed this record on July 06, 2009