Evaluation of the Endovascular Repair for Aortic Aneurysm (EVAR) Program at LHSC

• ClinicalTrials.gov Identifier: NCT00226629
• Recruitment Status: Completed
• First Posted: September 27, 2005
• Last Update Posted: August 25, 2017
• Sponsor: Lawson Health Research Institute
• Information provided by (Responsible Party): Lawson Health Research Institute

Tracking Information

• First Submitted Date: September 23, 2005
• First Posted Date: September 27, 2005
• Last Update Posted Date: August 25, 2017
• Actual Study Start Date: August 2003
• Actual Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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
• 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.
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Abdominal Aortic Aneurysm
• Intervention: Procedure: Endovascular vs Open Repair
• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Enrollment (submitted: September 23, 2005): 130
• Original Enrollment: Same as current
• Actual Study Completion Date: August 2007
• Actual Primary Completion Date: June 2006 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• infrarenal abdominal aortic aneurysm,
• > 5.5 cm diameter
• scheduled for elective surgical repair

Exclusion Criteria:

• previous repair of AAA

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 40 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Not Provided

Administrative Information

• NCT Number: NCT00226629
• Other Study ID Numbers: R-03-155
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

• IPD Sharing Statement: Not Provided
• Responsible Party: Lawson Health Research Institute
• Study Sponsor: Lawson Health Research Institute
• Collaborators: Not Provided

Investigators

• Principal Investigator: Gaetano DeRose, MD, FACS, FRCSC; LHSC, UWO

• PRS Account: Lawson Health Research Institute
• Verification Date: August 2017