NExT ERA: National Expertise Based Trial of Elective Repair of Abdominal Aortic Aneurysms: A Pilot Study
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|ClinicalTrials.gov Identifier: NCT00358085|
Recruitment Status : Unknown
Verified July 2006 by McMaster University.
Recruitment status was: Not yet recruiting
First Posted : July 28, 2006
Last Update Posted : July 28, 2006
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).
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 or disease||Intervention/treatment||Phase|
|Aortic Aneurysm, Abdominal||Procedure: Endovascular Repair of Abdominal Aortic Aneurysm Procedure: Conventional open repair of Abdominal Aortic Aneurysm||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Expertise Based Randomized Controlled Trial of Open Versus Endovascular Repair of Abdominal Aortic Aneurysms: A Pilot Study|
|Study Start Date :||September 2006|
|Study Completion Date :||January 2008|
- Mortality from the time of randomization until hospital discharge or 30-days after surgery
- Non-fatal myocardial infarction.
- End organ ischemic event rates (including Renal Failure, Limb ischemia, Bowel ischemia, Non-fatal stroke)
- Quality of life
- Success of repair
- Mortality at 6 months
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00358085
|Contact: Tara M Mastracci, MD, FRCSCfirstname.lastname@example.org|
|Contact: Claudio S Cina, MD, Spec Chir(It), FRCSC, MScemail@example.com|
|McMaster University, Hamilton General Hospital|
|Hamilton, Ontario, Canada|
|Contact: Tara M Mastracci, MD, FRCSC firstname.lastname@example.org|
|Contact: Claudio S Cina, MD, Spec Chir(It), FRCSC, MSc email@example.com|
|Principal Investigator: Tara M Mastracci, MD, FRCS(C)|
|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|