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OpenTrials
Completed

NCT Number: NCT00355940

Comparing Fluoroscopy and Technological Methods for Guidance During Endovascular Procedures

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

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Key information

Conditions

Aortic Aneurysm, Abdominal Aneurysm Aortic Aneurysm Aortic Diseases Cardiovascular Diseases Vascular Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

St Olavs Hospital

Trondheim, 7006, Norway

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Technological Methods

Device

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 names: Custom made devices in addition to Siemens angiography suite

Regular Fluoroscopy

Device

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 names: Siemens angiography suite

Primary outcomes

  1. Measure time (s) for defining renal branch

    Time frame: No time frame

  2. Measure time (s) for inserting guidewire into "second limb"

    Time frame: 900 sec

  3. Number of attempts for inserting guidewire into "second limb"

    Time frame: 900 sec

  4. Measure total time (min) for entire procedure

    Time frame: No time frame

  5. Measure the total of x-ray dose (mGy/m2)

    Time frame: No time frame

  6. Measure the total of contrast fluid used (ml)

    Time frame: No time frame

  7. Define type I leak between stent graft and aortic wall

    Time frame: No time frame

  8. Measure distance (mm) between stent graft and renal arteries

    Time frame: No time frame

  9. 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

  10. 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

Secondary outcomes

  1. 1 questionnaire: "Can 3D image and navigation technology simplify and secure endovascular procedures?"

    Time frame: No time frame

  2. 2 questionnaire: "Do you believe in further development of this technology?"

    Time frame: No time frame

  3. 3 questionnaire: "Have both renal arteries unaltered flow?"

    Time frame: No time frame

Sponsors and collaborators

Lead sponsor

Norwegian University of Science and Technology

Other

Collaborators

  • SINTEF Health Research
  • St. Olavs Hospital
  • The Research Council of Norway

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Jul 25, 2006
Registry last updated
Apr 29, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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