Image Fusion of Preprocedural CTA With Real Time Fluoroscopy to Enhance EVAR Repair
Primary Purpose
Abdominal Aortic Aneurysm (AAA)
Status
Unknown status
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Using pre-procedural CTA to guide advanced EVAR procedure
Sponsored by
About this trial
This is an interventional diagnostic trial for Abdominal Aortic Aneurysm (AAA)
Eligibility Criteria
Inclusion Criteria:
- male or female >= 18 years;
- scheduled for advanced EVAR for abdominal aortic aneurysm.
Exclusion Criteria:
- Pregnancy;
Sites / Locations
- Toronto General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
pre-procedure image guidance
Arm Description
Outcomes
Primary Outcome Measures
Procedure success
Evaluate the technical success of advanced EVAR by using pre-procedural CTA images as guidance
Secondary Outcome Measures
Full Information
NCT ID
NCT02295137
First Posted
October 27, 2014
Last Updated
November 14, 2014
Sponsor
University Health Network, Toronto
1. Study Identification
Unique Protocol Identification Number
NCT02295137
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2014
Overall Recruitment Status
Unknown status
Study Start Date
February 2014 (undefined)
Primary Completion Date
October 2015 (Anticipated)
Study Completion Date
October 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Health Network, Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm (AAA)
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
pre-procedure image guidance
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Using pre-procedural CTA to guide advanced EVAR procedure
Primary Outcome Measure Information:
Title
Procedure success
Description
Evaluate the technical success of advanced EVAR by using pre-procedural CTA images as guidance
Time Frame
within 1 day
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
male or female >= 18 years;
scheduled for advanced EVAR for abdominal aortic aneurysm.
Exclusion Criteria:
Pregnancy;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Kong Teng Tan, MD
Phone
416-340-4800
Ext
6166
Email
kongteng.tan@uhn.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kong Teng Tan, MD
Organizational Affiliation
University Health Network, Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1C4
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kong Teng Tan, MD
Phone
416-340-4800
Ext
6166
Email
kongteng.tan@uhn.ca
12. IPD Sharing Statement
Learn more about this trial
Image Fusion of Preprocedural CTA With Real Time Fluoroscopy to Enhance EVAR Repair
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