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NCT00226629 Clinical Trial

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

Abdominal Aortic Aneurysm Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00226629
Other study ID # R-03-155
Secondary ID
Status Completed
Phase N/A
First received September 23, 2005
Last updated August 24, 2017
Start date August 2003
Est. completion date August 2007

Study information
Verified date August 2017
Source Lawson Health Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 130
Est. completion date August 2007
Est. primary completion date June 2006
Accepts healthy volunteers No
Gender All
Age group 40 Years and older
Eligibility Inclusion Criteria:

- infrarenal abdominal aortic aneurysm,

- > 5.5 cm diameter

- scheduled for elective surgical repair

Exclusion Criteria:

- previous repair of AAA

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Endovascular vs Open Repair

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Lawson Health Research Institute
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