Acute Technical Outcomes of the Talent Abdominal Aortic Aneurysm (AAA) Stent-Graft Versus Cook Zenith Stent-Graft
NCT00922454 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200
Last updated 2009-06-17
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.
Conditions
- Abdominal Aortic Aneurysm
Interventions
- 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
Sponsors & Collaborators
-
Center for Vascular Awareness, Albany, New York
lead OTHER
Principal Investigators
-
Manish Mehta, MD, MPH · The Vascular Group, PLLC
Study Design
- Masking
- NONE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-06-30
- Primary Completion
- 2011-06-30
- Completion
- 2011-06-30
Countries
- United States
Study Locations
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