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

August 24, 2017 updated by: Lawson Health Research Institute
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment

130

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • previous repair of AAA

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2003

Primary Completion (Actual)

June 1, 2006

Study Completion (Actual)

August 1, 2007

Study Registration Dates

First Submitted

September 23, 2005

First Submitted That Met QC Criteria

September 23, 2005

First Posted (Estimate)

September 27, 2005

Study Record Updates

Last Update Posted (Actual)

August 25, 2017

Last Update Submitted That Met QC Criteria

August 24, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R-03-155

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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