Trial record 6 of 84 for:    Open Studies | "Aortic Aneurysm, Abdominal"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2006 by McMaster University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
The Physicians' Services Incorporated Foundation
Information provided by:
McMaster University
ClinicalTrials.gov Identifier:
NCT00358085
First received: July 26, 2006
Last updated: NA
Last verified: July 2006
History: No changes posted
  Purpose

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
Aortic Aneurysm, Abdominal
Procedure: Endovascular Repair of Abdominal Aortic Aneurysm
Procedure: Conventional open repair of Abdominal Aortic Aneurysm
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Expertise Based Randomized Controlled Trial of Open Versus Endovascular Repair of Abdominal Aortic Aneurysms: A Pilot Study

Resource links provided by NLM:


Further study details as provided by McMaster University:

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

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

Estimated Enrollment: 30
Study Start Date: September 2006
Estimated Study Completion Date: January 2008
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00358085

Contacts
Contact: Tara M Mastracci, MD, FRCSC mastratm@mcmaster.ca
Contact: Claudio S Cina, MD, Spec Chir(It), FRCSC, MSc cinacs@mcmaster.ca

Locations
Canada, Ontario
McMaster University, Hamilton General Hospital Not yet recruiting
Hamilton, Ontario, Canada
Contact: Tara M Mastracci, MD, FRCSC       mastratm@mcmaster.ca   
Contact: Claudio S Cina, MD, Spec Chir(It), FRCSC, MSc       cinacs@mcmaster.ca   
Principal Investigator: Tara M Mastracci, MD, FRCS(C)         
Sponsors and Collaborators
Hamilton Health Sciences Corporation
The Physicians' Services Incorporated Foundation
Investigators
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
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00358085     History of Changes
Other Study ID Numbers: unknown
Study First Received: July 26, 2006
Last Updated: July 26, 2006
Health Authority: Canada: Health Canada

Keywords provided by McMaster University:
Endovascular
Vascular Surgical Procedures
Aneurysm
Expertise Based Methodology

Additional relevant MeSH terms:
Aneurysm
Aortic Aneurysm
Aortic Aneurysm, Abdominal
Vascular Diseases
Cardiovascular Diseases
Aortic Diseases

ClinicalTrials.gov processed this record on July 20, 2014