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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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ClinicalTrials.gov Identifier: NCT00922454
Recruitment Status : Unknown
Verified June 2009 by Center for Vascular Awareness, Albany, New York.
Recruitment status was:  Recruiting
First Posted : June 17, 2009
Last Update Posted : June 17, 2009
Sponsor:
Information provided by:

June 16, 2009
June 17, 2009
June 17, 2009
June 2009
June 2011   (Final data collection date for primary outcome measure)
Acute technical success, successful exclusion of the aneurysm [ Time Frame: one year ]
Same as current
No Changes Posted
Not Provided
Not Provided
Not Provided
Not Provided
 
Acute Technical Outcomes of the Talent Abdominal Aortic Aneurysm (AAA) Stent-Graft Versus Cook Zenith Stent-Graft
Acute Technical Outcomes of the Talent AAA Stent -Graft vs. Cook Zenith Stent- Graft: A Case-Control Study

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.

Not Provided
Interventional
Not Provided
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Abdominal Aortic Aneurysm
  • Procedure: Endovascular Repair of the abdominal aorta

    Patients will undergo or have undergone endovascular aneurysm repair which is minimally invasive approach using endoluminal placement of a stent graft.

    EVAR, CTA imaging, 1, 6 12 months post treatment.

  • Device: Cook Zenith Stent-Graft
    Cook Zenith AAA Endovascular Graft
  • Device: Talent Stent-Graft
    Talent AAA Abdominal Stent Graft System
  • Experimental: Talent Stent-Graft
    Interventions:
    • Procedure: Endovascular Repair of the abdominal aorta
    • Device: Talent Stent-Graft
  • Experimental: Cook Zenith Stent-Graft
    Interventions:
    • Procedure: Endovascular Repair of the abdominal aorta
    • Device: Cook Zenith Stent-Graft
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
200
June 2011
June 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00922454
001
No
Not Provided
Not Provided
Manish Mehta, MD, The Vascular Group, PLLC
Center for Vascular Awareness, Albany, New York
Not Provided
Principal Investigator: Manish Mehta, MD, MPH The Vascular Group, PLLC
Center for Vascular Awareness, Albany, New York
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP