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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00226629
Recruitment Status : Completed
First Posted : September 27, 2005
Last Update Posted : August 25, 2017
Sponsor:
Information provided by (Responsible Party):
Lawson Health Research Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Abdominal Aortic Aneurysm Procedure: Endovascular vs Open Repair Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 130 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of the Endovascular Repair for Aortic Aneurysm (EVAR) Program at LHSC
Actual Study Start Date : August 2003
Actual Primary Completion Date : June 2006
Actual Study Completion Date : August 2007

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • previous repair of AAA
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00226629


Sponsors and Collaborators
Lawson Health Research Institute
Investigators
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Principal Investigator: Gaetano DeRose, MD, FACS, FRCSC LHSC, UWO
More Information
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Responsible Party: Lawson Health Research Institute
ClinicalTrials.gov Identifier: NCT00226629    
Other Study ID Numbers: R-03-155
First Posted: September 27, 2005    Key Record Dates
Last Update Posted: August 25, 2017
Last Verified: August 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases