Evaluation of the Endovascular Repair for Aortic Aneurysm (EVAR) Program at LHSC
Primary Purpose
Abdominal Aortic Aneurysm
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Endovascular vs Open Repair
Sponsored by
About this trial
This is an interventional treatment trial for Abdominal Aortic Aneurysm
Eligibility Criteria
Inclusion Criteria: infrarenal abdominal aortic aneurysm, > 5.5 cm diameter scheduled for elective surgical repair Exclusion Criteria: previous repair of AAA
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00226629
First Posted
September 23, 2005
Last Updated
August 24, 2017
Sponsor
Lawson Health Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT00226629
Brief Title
Evaluation of the Endovascular Repair for Aortic Aneurysm (EVAR) Program at LHSC
Official Title
Evaluation of the Endovascular Repair for Aortic Aneurysm (EVAR) Program at LHSC
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
August 2003 (Actual)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
August 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lawson Health Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the cost effectiveness, quality of life and outcomes of the endovascular stent graft repair with the open surgical repair of abdominal aortic aneurysms.
Detailed Description
Abdominal Aortic Aneurysms have been traditionally repaired using the standard open surgical technique. The use of Endovascular stent grafts(EVAR) to treat aortic aneurysms has been ongoing for approximately 8-10 years. Use of EVAR to treat aortic aneurysms in high risk has been reported to be beneficial. However, the costs of this therapy are quite significant and therefore in order to best understand the cost effectiveness of this type of aneurysm treatment, an extensive prospective comparative evaluation is required. This study will compare outcomes and cost-effectiveness for patients receiving EVAR, with high surgical risk, and OSR, with low surgical risk, and OSR, where there is high surgical risk and not suitable for EVAR based on anatomical complexity. Demographic, medical, health care resource utilization, cost, and quality of life information is collected from participating patients over a period of a year following repair.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Abdominal Aortic Aneurysm
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
130 (false)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Endovascular vs Open Repair
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
infrarenal abdominal aortic aneurysm,
> 5.5 cm diameter
scheduled for elective surgical repair
Exclusion Criteria:
previous repair of AAA
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gaetano DeRose, MD, FACS, FRCSC
Organizational Affiliation
LHSC, UWO
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Evaluation of the Endovascular Repair for Aortic Aneurysm (EVAR) Program at LHSC
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