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

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Abdominal aortic aneurysm
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Cook – Abdominal aortic aneurysm Cordis Corporation – Abdominal Aortic Aneurysm
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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

Condition

Abdominal Aortic Aneurysm

Intervention

Endovascular vs Open Repair

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

130

Start Date

August 2003

Completion Date

August 2007

Primary Completion Date

June 2006

Eligibility Criteria

        Inclusion Criteria:

          -  infrarenal abdominal aortic aneurysm,

          -  > 5.5 cm diameter

          -  scheduled for elective surgical repair

        Exclusion Criteria:

          -  previous repair of AAA

Gender

All

Ages

40 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Gaetano DeRose, MD, FACS, FRCSC, ,

Administrative Informations

NCT ID

NCT00226629

Organization ID

R-03-155

Responsible Party

Sponsor

Study Sponsor

Lawson Health Research Institute

Study Sponsor

Gaetano DeRose, MD, FACS, FRCSC, Principal Investigator, LHSC, UWO

Verification Date

August 2017