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
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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:


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 ]

Enrollment: 17
Study Start Date: August 2007
Study Completion Date: April 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: Siemens angiography suite

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
Norway
St Olavs Hospital
Trondheim, Norway, 7006
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

Publications:
Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT00355940     History of Changes
Other Study ID Numbers: STO-NTNU/DMF-SINTEF-1
Study First Received: July 24, 2006
Last Updated: April 26, 2013
Health Authority: Norway: Norwegian Social Science Data Services

Keywords provided by Norwegian University of Science and Technology:
endovascular
aortic
repair
navigation
DynaCT
position
sensor

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on July 20, 2014