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Clinical Trials/NCT02295137
NCT02295137
Unknown
Phase 1

Image Fusion of Pre-procedural CTA With Real-time Fluoroscopy to Guide Proper Renal and Visceral Arteries Catheterization During Advanced Endovascular Aortic Aneurysms Repair: A Feasibility Study

University Health Network, Toronto1 site in 1 country20 target enrollmentFebruary 2014

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Abdominal Aortic Aneurysm (AAA)
Sponsor
University Health Network, Toronto
Enrollment
20
Locations
1
Primary Endpoint
Procedure success
Last Updated
11 years ago

Overview

Brief Summary

Abdominal Aortic Aneurysm (AAA) is a potentially life threatening condition. If the aneurysm ruptures, the mortality can be as high as 80%. Endovascular aneurysms repair (EVAR) is a minimal invasive procedure and has been widely used on treating AAA. Advanced endovascular techniques are used to treat patients with more complex pathology by using custom-made devices and additional stents. In order to accomplish the technical success on advanced EVAR, with the current imaging equipment and technique for EVAR procedures (i.e. live x-ray fluoroscopy and 2-D digital subtraction angiography (DSA)), multiple angiograms on the target arteries (arteriograms) are required. Subsequently patients are exposed to higher dose of contrast and radiation, compared to conventional EVAR. This study is to assess the feasibility of proper visceral and renal arteries catheterization using a 3D model obtained from pre-procedural computed tomographic angiography (CTA), fused with real-time fluoroscopy, without contrast injection or angiographic run-offs thus minimizing the contrast use and patient radiation exposure while achieving procedure success during Advanced EVAR.

Registry
clinicaltrials.gov
Start Date
February 2014
End Date
October 2015
Last Updated
11 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • male or female \>= 18 years;
  • scheduled for advanced EVAR for abdominal aortic aneurysm.

Exclusion Criteria

  • Pregnancy;

Outcomes

Primary Outcomes

Procedure success

Time Frame: within 1 day

Evaluate the technical success of advanced EVAR by using pre-procedural CTA images as guidance

Study Sites (1)

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