Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparing Fluoroscopy and Technological Methods for Guidance During Endovascular Procedures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00355940
Recruitment Status : Completed
First Posted : July 25, 2006
Last Update Posted : April 29, 2013
Sponsor:
Collaborators:
SINTEF Health Research
St. Olavs Hospital
The Research Council of Norway
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Tracking Information
First Submitted Date  ICMJE July 24, 2006
First Posted Date  ICMJE July 25, 2006
Last Update Posted Date April 29, 2013
Study Start Date  ICMJE August 2007
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 14, 2007)
  • Measure time (s) for defining renal branch [ Time Frame: No time frame ]
  • Measure time (s) for inserting guidewire into "second limb" [ Time Frame: 900 sec ]
  • Number of attempts for inserting guidewire into "second limb" [ Time Frame: 900 sec ]
  • Measure total time (min) for entire procedure [ Time Frame: No time frame ]
  • Measure the total of x-ray dose (mGy/m2) [ Time Frame: No time frame ]
  • Measure the total of contrast fluid used (ml) [ Time Frame: No time frame ]
  • Define type I leak between stent graft and aortic wall [ Time Frame: No time frame ]
  • Measure distance (mm) between stent graft and renal arteries [ Time Frame: No time frame ]
  • 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 ]
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: July 24, 2006)
  • 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)
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 14, 2007)
  • 1 questionnaire: "Can 3D image and navigation technology simplify and secure endovascular procedures?" [ Time Frame: No time frame ]
  • 2 questionnaire: "Do you believe in further development of this technology?" [ Time Frame: No time frame ]
  • 3 questionnaire: "Have both renal arteries unaltered flow?" [ Time Frame: No time frame ]
Original Secondary Outcome Measures  ICMJE
 (submitted: July 24, 2006)
  • 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?"
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparing Fluoroscopy and Technological Methods for Guidance During Endovascular Procedures
Official Title  ICMJE Comparing Fluoroscopy and Technological Methods for Guidance During Endovascular Procedures Traditional Fluoroscopy Navigation Based on Preoperative CT and Intraoperative DynaCT
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Aortic Aneurysm, Abdominal
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: 1
    Intervention: Device: Technological Methods
  • Active Comparator: 2
    Intervention: Device: Regular Fluoroscopy
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 26, 2013)
17
Original Enrollment  ICMJE
 (submitted: July 24, 2006)
20
Actual Study Completion Date  ICMJE April 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Norway
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00355940
Other Study ID Numbers  ICMJE STO-NTNU/DMF-SINTEF-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Norwegian University of Science and Technology
Study Sponsor  ICMJE Norwegian University of Science and Technology
Collaborators  ICMJE
  • SINTEF Health Research
  • St. Olavs Hospital
  • The Research Council of Norway
Investigators  ICMJE
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
PRS Account Norwegian University of Science and Technology
Verification Date April 2013

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