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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:

Study Description
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.


Condition or disease Intervention/treatment
Abdominal Aortic Aneurysm Procedure: Endovascular Repair of the abdominal aorta Device: Cook Zenith Stent-Graft Device: Talent Stent-Graft

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: Acute Technical Outcomes of the Talent AAA Stent -Graft vs. Cook Zenith Stent- Graft: A Case-Control Study
Study Start Date : June 2009
Estimated Primary Completion Date : June 2011
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: Talent Stent-Graft 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: Talent Stent-Graft
Talent AAA Abdominal Stent Graft System
Experimental: Cook Zenith Stent-Graft 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


Outcome Measures

Primary Outcome Measures :
  1. Acute technical success, successful exclusion of the aneurysm [ Time Frame: one year ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00922454


Contacts
Contact: Deborah Hill, RN 518 45202198 hilld@albanyvascular.com
Contact: Anita Suchdeve, RN 518 452-1263 suchdevea@albanyvascular.com

Locations
United States, New York
Albany Medical Center, 47 New Scotland Ave. Recruiting
Albany, New York, United States, 12208
Contact: Anita Suchdeve, RN    518-452-1263    suchdevea@albanyvascular.com   
Contact: Deborah Hill, RN    (518) 452-1298    hilld@albanyvascular.com   
Sponsors and Collaborators
Center for Vascular Awareness, Albany, New York
Investigators
Principal Investigator: Manish Mehta, MD, MPH The Vascular Group, PLLC
More Information

Responsible Party: Manish Mehta, MD, The Vascular Group, PLLC
ClinicalTrials.gov Identifier: NCT00922454     History of Changes
Other Study ID Numbers: 001
First Posted: June 17, 2009    Key Record Dates
Last Update Posted: June 17, 2009
Last Verified: June 2009

Keywords provided by Center for Vascular Awareness, Albany, New York:
patients will be matched based on AAA neck length and neck and iliac angulation

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