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

This study has been completed.
Sponsor:
Information provided by:
Lawson Health Research Institute
ClinicalTrials.gov Identifier:
NCT00226629
First received: September 23, 2005
Last updated: April 24, 2006
Last verified: April 2006
History of Changes
  Purpose

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 Intervention
Abdominal Aortic Aneurysm
 Procedure: Endovascular vs Open Repair

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of the Endovascular Repair for Aortic Aneurysm (EVAR) Program at LHSC

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lawson Health Research Institute:

Estimated Enrollment: 130
Study Start Date: August 2003
Estimated Study Completion Date: August 2007
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.

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00226629

Sponsors and Collaborators
Lawson Health Research Institute
Investigators
Principal Investigator: Gaetano DeRose, MD, FACS, FRCSC LHSC, UWO
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00226629     History of Changes
Other Study ID Numbers: R-03-155
Study First Received: September 23, 2005
Last Updated: April 24, 2006
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
 Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on May 16, 2013