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Comparing Fluoroscopy and Technological Methods for Guidance During Endovascular Procedures

This study has been completed.
Sponsor:
Collaborators:
SINTEF Health Research
St. Olavs Hospital
The Research Council of Norway
Information provided by (Responsible Party):
Norwegian University of Science and Technology
ClinicalTrials.gov Identifier:
NCT00355940
First received: July 24, 2006
Last updated: April 26, 2013
Last verified: April 2013

July 24, 2006
April 26, 2013
August 2007
January 2010   (final data collection date for primary outcome measure)
  • 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 ]
  • Measure time (s) for defining renal branch
  • Measure time (s) for inserting guidewire into "second limb"
  • Number of attempts for inserting guidewire into "second limb"
  • Measure total time (min) for entire procedure
  • Measure the total of x-ray dose (mGy/m2)
  • Measure the total of contrast fluid used (ml)
  • Define type I leak between stentgraft and aortic wall
  • Measure distance (mm) between stentgraft and renal arteries
  • Measure difference (mm) in actual position and position in 3D image when pointing at the femoral division with an optic pointer
  • Measure difference (mm) of the position of the renal arteries defined by optical poiner and angiography (both marked extracoporal with a needle)
Complete list of historical versions of study NCT00355940 on ClinicalTrials.gov Archive Site
  • 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 ]
  • 1 questionnaire: "Can 3D image and navigation technology simplify and secure endovascular procedures?"
  • 2 questionnaire: "Do you belive in further development of this technology?"
  • 3 questionnaire: "Have both renal arteries unaltered flow?"
Not Provided
Not Provided
 
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
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Aortic Aneurysm, Abdominal
  • 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 Name: Custom made devices in addition to Siemens angiography suite
  • 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 Name: Siemens angiography suite
  • Experimental: 1
    Intervention: Device: Technological Methods
  • Active Comparator: 2
    Intervention: Device: Regular Fluoroscopy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
April 2010
January 2010   (final data collection date for primary outcome measure)

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
Both
60 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Norway
 
NCT00355940
STO-NTNU/DMF-SINTEF-1
No
Norwegian University of Science and Technology
Norwegian University of Science and Technology
  • SINTEF Health Research
  • St. Olavs Hospital
  • The Research Council of Norway
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
Norwegian University of Science and Technology
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP