Brief Title
Image Fusion of Preprocedural CTA With Real Time Fluoroscopy to Enhance EVAR Repair
Official Title
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
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.
Study Phase
Phase 1
Study Type
Interventional
Primary Outcome
Procedure success
Condition
Abdominal Aortic Aneurysm (AAA)
Intervention
Using pre-procedural CTA to guide advanced EVAR procedure
Study Arms / Comparison Groups
pre-procedure image guidance
Description:
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Procedure
Estimated Enrollment
20
Start Date
February 2014
Completion Date
October 2015
Primary Completion Date
October 2015
Eligibility Criteria
Inclusion Criteria: - male or female >= 18 years; - scheduled for advanced EVAR for abdominal aortic aneurysm. Exclusion Criteria: - Pregnancy;
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Kong Teng Tan, MD, 416-340-4800, [email protected]
Location Countries
Canada
Location Countries
Canada
Administrative Informations
NCT ID
NCT02295137
Organization ID
UHN
Responsible Party
Sponsor
Study Sponsor
University Health Network, Toronto
Study Sponsor
Kong Teng Tan, MD, Principal Investigator, University Health Network, Toronto
Verification Date
October 2014