Comparing Fluoroscopy and Technological Methods for Guidance During Endovascular Procedures

NCT ID: NCT00355940

Last Updated: 2013-04-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 17 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-08-31
• Study Completion Date: 2010-04-30

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

Conditions

Aortic Aneurysm, Abdominal

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Technological Methods

Intervention Type: 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

2

Group Type: ACTIVE_COMPARATOR

Regular Fluoroscopy

Intervention Type: 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).

Interventions

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

Intervention Type: 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).

Intervention Type: DEVICE

Other Intervention Names

Custom made devices in addition to Siemens angiography suite; Siemens angiography suite

Eligibility 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

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

SINTEF Health Research

OTHER

Sponsor Role: collaborator

St. Olavs Hospital

OTHER

Sponsor Role: collaborator

The Research Council of Norway

OTHER

Sponsor Role: collaborator

Norwegian University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frode Manstad-Hulaas, MD

Role: PRINCIPAL_INVESTIGATOR

Norwegian University of Science and Technology

Petter Aadahl, Professor

Role: STUDY_DIRECTOR

Norwegian University of Science and Technology

Toril N Hernes, Professor

Role: STUDY_DIRECTOR

SINTEF Health Research

Locations

St Olavs Hospital

Trondheim, , Norway

Countries

Norway

References

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.

Reference Type: RESULT

PMID: 22313205 (View on PubMed)

Other Identifiers

STO-NTNU/DMF-SINTEF-1

Identifier Type: -

Identifier Source: org_study_id