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Acute Technical Outcomes of the Talent Abdominal Aortic Aneurysm (AAA) Stent-Graft Versus Cook Zenith Stent-Graft

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Disease Information

Descriptive Information
Brief Title † Acute Technical Outcomes of the Talent Abdominal Aortic Aneurysm (AAA) Stent-Graft Versus Cook Zenith Stent-Graft
Official Title † Acute Technical Outcomes of the Talent AAA Stent -Graft vs. Cook Zenith Stent- Graft: A Case-Control Study
Brief Summary The purpose of this study is to compare acute technical outcomes of the Talent AAA Stent Graft system versus Cook Zenith Endograft at two high volume institutions, Albany Medical Center and St. Peter's Hospital in Albany, NY. The investigators are comparing the two devices as part of the evolution of endovascular repair (EVAR) for AAAs. The Zenith AAA Endovascular Graft received FDA approval on May 23, 2003, the Talent Abdominal Stent Graft System on April 15, 2008.
Detailed Description
Study Phase N/A
Study Type † Interventional
Study Design † Intervention Model: Crossover Assignment, Masking: Open Label
Primary Outcome Measure † Acute technical success, successful exclusion of the aneurysm
Secondary Outcome Measure †
Condition † Abdominal Aortic Aneurysm
Intervention † ProcedureEndovascular Repair of the abdominal aorta
Study Arms / Comparison Groups Talent Stent-Graft Cook Zenith Stent-Graft
Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status † Procedure
Estimated Enrollment † 200
Start Date † June 2009
Completion Date June 2011
Primary Completion Date June 2011
Eligibility Criteria † Inclusion Criteria: - subject with abdominal aortic aneurysm, with or without iliac involvement - iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories Exclusion Criteria: - less than 18 years of age - pregnant or lactating - have contraindications for use of contrast medium or anticoagulation drugs - are patients who have a condition that threatens to infect the graft - are patients with sensitivities or allergies to the device materials
Gender Both
Ages 18 Years - N/A
Accepts Healthy Volunteers No
Contacts †† Deborah Hill, RN, 518 45202198, hilld@albanyvascular.com
Location Countries † United States
Administrative Information
NCT ID † NCT00922454
Organization ID 001
Secondary IDs ††
Responsible Party
Study Sponsor † Center for Vascular Awareness, Albany, New York
Collaborators ††
Investigators † Principal Investigator: Manish Mehta, MD, MPH, The Vascular Group, PLLC
Information Provided By
Verification Date June 2009
First Received Date † June 16, 2009
Last Updated Date June 16, 2009
† Required WHO trial registration data element.
†† WHO trial registration data element that is required only if it exists.
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