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

NCT ID: NCT00226629

Last Updated: 2017-08-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-08-31
• Study Completion Date: 2007-08-31

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.

Conditions

Abdominal Aortic Aneurysm

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Endovascular vs Open Repair

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• previous repair of AAA

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gaetano DeRose, MD, FACS, FRCSC

Role: PRINCIPAL_INVESTIGATOR

LHSC, UWO

Other Identifiers

R-03-155

Identifier Type: -

Identifier Source: org_study_id