Acute Technical Outcomes of the Talent Abdominal Aortic Aneurysm (AAA) Stent-Graft Versus Cook Zenith Stent-Graft
1 other identifier
interventional
200
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2009
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 16, 2009
CompletedFirst Posted
Study publicly available on registry
June 17, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2011
CompletedJune 17, 2009
June 1, 2009
2 years
June 16, 2009
June 16, 2009
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Acute technical success, successful exclusion of the aneurysm
one year
Study Arms (2)
Talent Stent-Graft
EXPERIMENTALCook Zenith Stent-Graft
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Albany Medical Center, 47 New Scotland Ave.
Albany, New York, 12208, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Manish Mehta, MD, MPH
The Vascular Group, PLLC
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Masking
- NONE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
June 16, 2009
First Posted
June 17, 2009
Study Start
June 1, 2009
Primary Completion
June 1, 2011
Study Completion
June 1, 2011
Last Updated
June 17, 2009
Record last verified: 2009-06