Acute Technical Outcomes of the Talent Abdominal Aortic Aneurysm (AAA) Stent-Graft Versus Cook Zenith Stent-Graft
NCT ID: NCT00922454
Last Updated: 2009-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
200 participants
INTERVENTIONAL
2009-06-30
2011-06-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CROSSOVER
NONE
Study Groups
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Talent Stent-Graft
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.
Talent Stent-Graft
Talent AAA Abdominal Stent Graft System
Cook Zenith Stent-Graft
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.
Cook Zenith Stent-Graft
Cook Zenith AAA Endovascular Graft
Interventions
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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.
Cook Zenith Stent-Graft
Cook Zenith AAA Endovascular Graft
Talent Stent-Graft
Talent AAA Abdominal Stent Graft System
Eligibility Criteria
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Inclusion Criteria
* iliac/femoral access vessel morphology that is compatible with vascular access techniques, devices, and/or accessories
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Center for Vascular Awareness, Albany, New York
OTHER
Responsible Party
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The Vascular Group, PLLC
Principal Investigators
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Manish Mehta, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
The Vascular Group, PLLC
Locations
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Albany Medical Center, 47 New Scotland Ave.
Albany, New York, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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001
Identifier Type: -
Identifier Source: org_study_id
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