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

Primary Purpose

Abdominal Aortic Aneurysm

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Endovascular vs Open Repair
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Abdominal Aortic Aneurysm

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: infrarenal abdominal aortic aneurysm, > 5.5 cm diameter scheduled for elective surgical repair Exclusion Criteria: previous repair of AAA

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    September 23, 2005
    Last Updated
    August 24, 2017
    Sponsor
    Lawson Health Research Institute
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00226629
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    August 2003 (Actual)
    Primary Completion Date
    June 2006 (Actual)
    Study Completion Date
    August 2007 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Lawson Health Research Institute

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Abdominal Aortic Aneurysm

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    130 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Procedure
    Intervention Name(s)
    Endovascular vs Open Repair

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: infrarenal abdominal aortic aneurysm, > 5.5 cm diameter scheduled for elective surgical repair Exclusion Criteria: previous repair of AAA
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Gaetano DeRose, MD, FACS, FRCSC
    Organizational Affiliation
    LHSC, UWO
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

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

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