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NExT ERA: National Expertise Based Trial of Elective Repair of Abdominal Aortic Aneurysms: A Pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
The Physicians' Services Incorporated Foundation
Information provided by:
McMaster University

Brief Summary:


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 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

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Study Type : Interventional  (Clinical Trial)
Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Mortality from the time of randomization until hospital discharge or 30-days after surgery

Secondary Outcome Measures :
  1. Non-fatal myocardial infarction.
  2. End organ ischemic event rates (including Renal Failure, Limb ischemia, Bowel ischemia, Non-fatal stroke)
  3. Reintervention
  4. Quality of life
  5. Success of repair
  6. Mortality at 6 months

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
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.)

  1. Neck Length (20 - 15 mm = 1; 14 - 10 mm = 2)
  2. Quality of Neck (Thrombus 90 -180 º = 1, 181-270 º = 2; calcification 90 -180 º = 1; 181-270 º = 2)
  3. Presence/absence side branches (IMA or lumbar vessels = 1; IMA and lumbar vessels or other = 2)
  4. Landing zone (aneurysmal or occlusive disease = 1; aneurysmal and occlusive disease = 2;
  5. Degree of calcification of aorta (25 - 50% calcification = 1; > 50% = 2)
  6. Access (stenosis = 1; stenosis and tortuosity =2)
  7. Stenting of accessory renal arteries necessary
  8. Embolization of internal iliac artery necessary

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:

  1. Exclusion due to Medical Risk: Patients with severe cardiac or respiratory disease that limits their activities of daily living and would make them ineligible for open repair. BMI greater than 45. Any known diagnosis or condition that renders a lift span of less than 2 years based on available and tolerable treatments.
  2. Exclusion due to Aneurysm Factors: Patients with ruptured or symptomatic aneurysms requiring urgent surgery. Any aneurysm that extends proximal to the renal arteries (suprarenal), involves the renal arteries or is less than 15mm distal to the level of the lowest renal artery.
  3. Exclusion due to Operative Factors: Patients with multiple previous laparotomies making open repair contraindicated due to adhesions (a 'hostile abdomen'). Any patients with stomas or exteriorized bowel. Patients with previous abdominal radiation, Fitz-Hugh-Curtis, or history of other conditions that would render open operative intervention contraindicated.

Information from the National Library of Medicine

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 identifier (NCT number): NCT00358085

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Contact: Tara M Mastracci, MD, FRCSC
Contact: Claudio S Cina, MD, Spec Chir(It), FRCSC, MSc

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Canada, Ontario
McMaster University, Hamilton General Hospital
Hamilton, Ontario, Canada
Contact: Tara M Mastracci, MD, FRCSC   
Contact: Claudio S Cina, MD, Spec Chir(It), FRCSC, MSc   
Principal Investigator: Tara M Mastracci, MD, FRCS(C)         
Sponsors and Collaborators
Hamilton Health Sciences Corporation
The Physicians' Services Incorporated Foundation
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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
Layout table for additonal information Identifier: NCT00358085    
First Posted: July 28, 2006    Key Record Dates
Last Update Posted: July 28, 2006
Last Verified: July 2006
Keywords provided by McMaster University:
Vascular Surgical Procedures
Expertise Based Methodology
Additional relevant MeSH terms:
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Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases