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Sponsors and Collaborators: |
Hamilton Health Sciences The Physicians' Services Incorporated Foundation |
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Information provided by: | McMaster University |
ClinicalTrials.gov Identifier: | NCT00358085 |
Objectives.
To study the feasibility of an expertise-based randomized controlled trial (RCT) testing the role of traditional surgery (OPEN) versus endovascular repair (EVAR) for abdominal aortic aneurysms (AAA).
Study design.
We will conduct an expertise-based RCT comparing OPEN to EVAR of non-urgent abdominal aortic aneurysms in patients referred to vascular surgeons practicing at Hamilton Health Sciences, to determine the rate of death and other complications. Quality of life and status at 6 months will also be recorded. The ultimate goal is to determine the feasibility of conducting a pragmatic expertise-based RCT and to inform a future larger study at a national level.
Condition | Intervention | Phase |
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Aortic Aneurysm, Abdominal |
Procedure: Endovascular Repair of Abdominal Aortic Aneurysm Procedure: Conventional open repair of Abdominal Aortic Aneurysm |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Expertise Based Randomized Controlled Trial of Open Versus Endovascular Repair of Abdominal Aortic Aneurysms: A Pilot Study |
Estimated Enrollment: | 30 |
Study Start Date: | September 2006 |
Estimated Study Completion Date: | January 2008 |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
All patients with an AAA determined to require non-urgent repair after assessment by one of the participating surgeons will be considered. Patients must meet two eligibility criteria: Medical and Anatomic.
Medical Fitness for surgery will mean that the patient is a candidate for elective open repair, and has none of the exclusion criteria listed below.
Anatomic Eligibility will be judged by the endovascular measurement team, and will be based on a score of < 3 on the following scale. (This scale was developed at our centre and is currently being validated.)
Definition of Surgical Experts
Expertise in endovascular surgery will be determined by completion of a vascular residency at a credentialed academic centre, a period of study in a formal training programme dedicated to acquiring endovascular expertise, and experience with at least 60 previous EVAR procedures.30
Expertise in open aortic repair will require completion of an accredited vascular surgery residency programme and demonstration of expertise by having completed at least 100 consecutive elective AAA repairs in their career.32
Endovascular Measurement Team The Endovascular Measurement team consists of at least one vascular surgeon with expertise in endovascular surgery, at least one vascular fellow in his/her first or second year of training and a representative from an endovascular graft specialist who is familiar with graft measurement and deployment. This team, blinded to patient demographics and surgical fitness, will judge anatomic eligibility.
Exclusion Criteria:
Contact: Tara M Mastracci, MD, FRCSC | mastratm@mcmaster.ca | |
Contact: Claudio S Cina, MD, Spec Chir(It), FRCSC, MSc | cinacs@mcmaster.ca |
Canada, Ontario | |
McMaster University, Hamilton General Hospital | |
Hamilton, Ontario, Canada |
Principal Investigator: | Tara M Mastracci, MD, FRCSC | McMaster University |
Study Director: | Claudio S Cina, MD, Spec Chir(It), FRCSC, MSc | McMaster University |
Study Director: | Catherine M Clase, MD, FRCSC, MSc | McMaster University |
Study Director: | PJ Devereaux, MD, FRCSC, PhD | McMaster University |
Study ID Numbers: | unknown |
Study First Received: | July 26, 2006 |
Last Updated: | July 26, 2006 |
ClinicalTrials.gov Identifier: | NCT00358085 |
Health Authority: | Canada: Health Canada |
Endovascular Vascular Surgical Procedures Aneurysm Expertise Based Methodology |
Aortic Diseases Aneurysm Aortic Aneurysm, Abdominal |
Abdominal aortic aneurysm Vascular Diseases Aortic Aneurysm |
Cardiovascular Diseases |